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NCT05243641

Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

Version 14 to 15 · M.D. Anderson Cancer Center

Patch inspector

Version 14 to 15

321 operations 3 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
adverse_event_group_changeother_adverse_event_additionother_adverse_event_modificationserious_adverse_event_additionserious_adverse_event_modification
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:34+00
Raw hash
910374f683b05bf8b3a2a30ccfebf33abf05c42ae71774869d31b68c8f08decd
Payload
Source URL
Adverse events and safety Posted serious or other adverse event data. Triage: High 213 ops
replace /resultsSection/adverseEventsModule/frequencyThreshold
Triage: Uncategorized
Uncategorized Operation 107
Before
4
After
0
replace /resultsSection/adverseEventsModule/eventGroups/0/title
Triage: High
Adverse Event Group Change Operation 108
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
Phase Ib
After
Phase Ib: Dose Level 1
replace /resultsSection/adverseEventsModule/eventGroups/0/description
Triage: High
Adverse Event Group Change Operation 109
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
Dose Escalation of Neratinib with Capmatinib uses a 3+3 design.
Max 18 patients, treated in cohorts of 3, with safety data reviewed after each cohort's DLT period.
After
Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily
replace /resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected
Triage: High
Adverse Event Group Change Operation 110
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk
Triage: High
Adverse Event Group Change Operation 111
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
10
After
7
replace /resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected
Triage: High
Adverse Event Group Change Operation 112
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
2
After
1
replace /resultsSection/adverseEventsModule/eventGroups/0/seriousNumAtRisk
Triage: High
Adverse Event Group Change Operation 113
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
10
After
7
replace /resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected
Triage: High
Adverse Event Group Change Operation 114
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
10
After
7
replace /resultsSection/adverseEventsModule/eventGroups/0/otherNumAtRisk
Triage: High
Adverse Event Group Change Operation 115
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
10
After
7
replace /resultsSection/adverseEventsModule/eventGroups/1/title
Triage: High
Adverse Event Group Change Operation 116
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
Phase II
After
Phase Ib: Dose Level 2
replace /resultsSection/adverseEventsModule/eventGroups/1/description
Triage: High
Adverse Event Group Change Operation 117
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
Subjects receive neratinib and capmatinib.
The MTD determined during Phase Ib will be used.
After
Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily
add /resultsSection/adverseEventsModule/eventGroups/2
Triage: High
Adverse Event Group Change Operation 118
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
After
{
  "id": "EG002",
  "title": "Phase Ib: Dose Level 3",
  "description": "Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily",
  "otherNumAtRisk": 0,
  "deathsNumAtRisk": 0,
  "otherNumAffected": 0,
  "seriousNumAtRisk": 0,
  "deathsNumAffected": 0,
  "seriousNumAffected": 0
}
add /resultsSection/adverseEventsModule/eventGroups/3
Triage: High
Adverse Event Group Change Operation 119
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
After
{
  "id": "EG003",
  "title": "Phase Ib: Dose Level-1",
  "description": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily",
  "otherNumAtRisk": 3,
  "deathsNumAtRisk": 3,
  "otherNumAffected": 3,
  "seriousNumAtRisk": 3,
  "deathsNumAffected": 1,
  "seriousNumAffected": 1
}
add /resultsSection/adverseEventsModule/eventGroups/4
Triage: High
Adverse Event Group Change Operation 120
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
After
{
  "id": "EG004",
  "title": "Phase Ib: Dose Level-2",
  "description": "Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily",
  "otherNumAtRisk": 0,
  "deathsNumAtRisk": 0,
  "otherNumAffected": 0,
  "seriousNumAtRisk": 0,
  "deathsNumAffected": 0,
  "seriousNumAffected": 0
}
add /resultsSection/adverseEventsModule/eventGroups/5
Triage: High
Adverse Event Group Change Operation 121
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
After
{
  "id": "EG005",
  "title": "Phase II",
  "description": "Subjects receive neratinib and capmatinib.\nThe MTD determined during Phase Ib will be used.",
  "otherNumAtRisk": 0,
  "deathsNumAtRisk": 0,
  "otherNumAffected": 0,
  "seriousNumAtRisk": 0,
  "deathsNumAffected": 0,
  "seriousNumAffected": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 122
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/seriousEvents/0/stats/2
Triage: High
Serious Adverse Event Addition Operation 123
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/0/stats/3
Triage: High
Serious Adverse Event Addition Operation 124
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/0/stats/4
Triage: High
Serious Adverse Event Addition Operation 125
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/0/stats/5
Triage: High
Serious Adverse Event Addition Operation 126
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 127
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 128
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/seriousEvents/1/stats/2
Triage: High
Serious Adverse Event Addition Operation 129
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/1/stats/3
Triage: High
Serious Adverse Event Addition Operation 130
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/1/stats/4
Triage: High
Serious Adverse Event Addition Operation 131
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/1/stats/5
Triage: High
Serious Adverse Event Addition Operation 132
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 133
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 134
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/seriousEvents/2/stats/2
Triage: High
Serious Adverse Event Addition Operation 135
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/2/stats/3
Triage: High
Serious Adverse Event Addition Operation 136
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/2/stats/4
Triage: High
Serious Adverse Event Addition Operation 137
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/2/stats/5
Triage: High
Serious Adverse Event Addition Operation 138
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/3/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 139
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/3/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 140
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/seriousEvents/3/stats/2
Triage: High
Serious Adverse Event Addition Operation 141
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/3/stats/3
Triage: High
Serious Adverse Event Addition Operation 142
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/3/stats/4
Triage: High
Serious Adverse Event Addition Operation 143
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/3/stats/5
Triage: High
Serious Adverse Event Addition Operation 144
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 145
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/0/stats/2
Triage: Medium
Other Adverse Event Addition Operation 146
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/0/stats/3
Triage: Medium
Other Adverse Event Addition Operation 147
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/0/stats/4
Triage: Medium
Other Adverse Event Addition Operation 148
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/0/stats/5
Triage: Medium
Other Adverse Event Addition Operation 149
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/1/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 150
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
3
replace /resultsSection/adverseEventsModule/otherEvents/1/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 151
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/1/stats/2
Triage: Medium
Other Adverse Event Addition Operation 152
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/1/stats/3
Triage: Medium
Other Adverse Event Addition Operation 153
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/1/stats/4
Triage: Medium
Other Adverse Event Addition Operation 154
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/1/stats/5
Triage: Medium
Other Adverse Event Addition Operation 155
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/2/term
Triage: Medium
Other Adverse Event Modification Operation 156
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Anorexia
After
Alkaline Phosphatase Increased
replace /resultsSection/adverseEventsModule/otherEvents/2/organSystem
Triage: Medium
Other Adverse Event Modification Operation 157
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Metabolism and nutrition disorders
After
Investigations
replace /resultsSection/adverseEventsModule/otherEvents/2/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 158
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
1
replace /resultsSection/adverseEventsModule/otherEvents/2/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 159
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/2/stats/2
Triage: Medium
Other Adverse Event Addition Operation 160
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/2/stats/3
Triage: Medium
Other Adverse Event Addition Operation 161
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/2/stats/4
Triage: Medium
Other Adverse Event Addition Operation 162
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/2/stats/5
Triage: Medium
Other Adverse Event Addition Operation 163
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/3/term
Triage: Medium
Other Adverse Event Modification Operation 164
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Arthralgia
After
Anemia
replace /resultsSection/adverseEventsModule/otherEvents/3/organSystem
Triage: Medium
Other Adverse Event Modification Operation 165
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Musculoskeletal and connective tissue disorders
After
Blood and lymphatic system disorders
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 166
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
1
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 167
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/3/stats/2
Triage: Medium
Other Adverse Event Addition Operation 168
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/3/stats/3
Triage: Medium
Other Adverse Event Addition Operation 169
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/3/stats/4
Triage: Medium
Other Adverse Event Addition Operation 170
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/3/stats/5
Triage: Medium
Other Adverse Event Addition Operation 171
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/4/term
Triage: Medium
Other Adverse Event Modification Operation 172
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Constipation
After
Anorexia
replace /resultsSection/adverseEventsModule/otherEvents/4/organSystem
Triage: Medium
Other Adverse Event Modification Operation 173
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Gastrointestinal disorders
After
Metabolism and nutrition disorders
replace /resultsSection/adverseEventsModule/otherEvents/4/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 174
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
3
replace /resultsSection/adverseEventsModule/otherEvents/4/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 175
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/4/stats/2
Triage: Medium
Other Adverse Event Addition Operation 176
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/4/stats/3
Triage: Medium
Other Adverse Event Addition Operation 177
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/4/stats/4
Triage: Medium
Other Adverse Event Addition Operation 178
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/4/stats/5
Triage: Medium
Other Adverse Event Addition Operation 179
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/5/term
Triage: Medium
Other Adverse Event Modification Operation 180
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Dehydration
After
Arthralgia
replace /resultsSection/adverseEventsModule/otherEvents/5/organSystem
Triage: Medium
Other Adverse Event Modification Operation 181
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Metabolism and nutrition disorders
After
Musculoskeletal and connective tissue disorders
replace /resultsSection/adverseEventsModule/otherEvents/5/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 182
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
3
replace /resultsSection/adverseEventsModule/otherEvents/5/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 183
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/5/stats/2
Triage: Medium
Other Adverse Event Addition Operation 184
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/5/stats/3
Triage: Medium
Other Adverse Event Addition Operation 185
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/5/stats/4
Triage: Medium
Other Adverse Event Addition Operation 186
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/5/stats/5
Triage: Medium
Other Adverse Event Addition Operation 187
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/6/term
Triage: Medium
Other Adverse Event Modification Operation 188
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Diarrhea
After
Aspartate Aminotransferase Increased
replace /resultsSection/adverseEventsModule/otherEvents/6/organSystem
Triage: Medium
Other Adverse Event Modification Operation 189
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Gastrointestinal disorders
After
Investigations
replace /resultsSection/adverseEventsModule/otherEvents/6/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 190
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
8
After
2
replace /resultsSection/adverseEventsModule/otherEvents/6/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 191
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/6/stats/2
Triage: Medium
Other Adverse Event Addition Operation 192
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/6/stats/3
Triage: Medium
Other Adverse Event Addition Operation 193
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/6/stats/4
Triage: Medium
Other Adverse Event Addition Operation 194
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/6/stats/5
Triage: Medium
Other Adverse Event Addition Operation 195
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/7/term
Triage: Medium
Other Adverse Event Modification Operation 196
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Dizziness
After
Back Pain
replace /resultsSection/adverseEventsModule/otherEvents/7/organSystem
Triage: Medium
Other Adverse Event Modification Operation 197
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Nervous system disorders
After
Musculoskeletal and connective tissue disorders
replace /resultsSection/adverseEventsModule/otherEvents/7/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 198
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
2
replace /resultsSection/adverseEventsModule/otherEvents/7/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 199
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/7/stats/2
Triage: Medium
Other Adverse Event Addition Operation 200
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/7/stats/3
Triage: Medium
Other Adverse Event Addition Operation 201
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/7/stats/4
Triage: Medium
Other Adverse Event Addition Operation 202
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/7/stats/5
Triage: Medium
Other Adverse Event Addition Operation 203
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/8/term
Triage: Medium
Other Adverse Event Modification Operation 204
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Fatigue
After
Blood Lactate Dehydrogenase Increased
replace /resultsSection/adverseEventsModule/otherEvents/8/organSystem
Triage: Medium
Other Adverse Event Modification Operation 205
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
General disorders
After
Investigations
replace /resultsSection/adverseEventsModule/otherEvents/8/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 206
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
9
After
1
replace /resultsSection/adverseEventsModule/otherEvents/8/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 207
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/8/stats/2
Triage: Medium
Other Adverse Event Addition Operation 208
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/8/stats/3
Triage: Medium
Other Adverse Event Addition Operation 209
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/8/stats/4
Triage: Medium
Other Adverse Event Addition Operation 210
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/8/stats/5
Triage: Medium
Other Adverse Event Addition Operation 211
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/9/term
Triage: Medium
Other Adverse Event Modification Operation 212
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Headache
After
Cardiac Disorders - Chest tightness
replace /resultsSection/adverseEventsModule/otherEvents/9/organSystem
Triage: Medium
Other Adverse Event Modification Operation 213
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Nervous system disorders
After
Cardiac disorders
replace /resultsSection/adverseEventsModule/otherEvents/9/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 214
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
1
replace /resultsSection/adverseEventsModule/otherEvents/9/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 215
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/9/stats/2
Triage: Medium
Other Adverse Event Addition Operation 216
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/9/stats/3
Triage: Medium
Other Adverse Event Addition Operation 217
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/9/stats/4
Triage: Medium
Other Adverse Event Addition Operation 218
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/9/stats/5
Triage: Medium
Other Adverse Event Addition Operation 219
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/10/term
Triage: Medium
Other Adverse Event Modification Operation 220
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Hypoalbuminemia
After
Cardiac Troponin T Increased
replace /resultsSection/adverseEventsModule/otherEvents/10/organSystem
Triage: Medium
Other Adverse Event Modification Operation 221
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Metabolism and nutrition disorders
After
Investigations
replace /resultsSection/adverseEventsModule/otherEvents/10/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 222
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
5
After
0
replace /resultsSection/adverseEventsModule/otherEvents/10/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 223
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/10/stats/2
Triage: Medium
Other Adverse Event Addition Operation 224
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/10/stats/3
Triage: Medium
Other Adverse Event Addition Operation 225
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/10/stats/4
Triage: Medium
Other Adverse Event Addition Operation 226
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/10/stats/5
Triage: Medium
Other Adverse Event Addition Operation 227
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/11/term
Triage: Medium
Other Adverse Event Modification Operation 228
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Myalgia
After
Constipation
replace /resultsSection/adverseEventsModule/otherEvents/11/organSystem
Triage: Medium
Other Adverse Event Modification Operation 229
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Musculoskeletal and connective tissue disorders
After
Gastrointestinal disorders
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 230
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
3
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 231
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/11/stats/2
Triage: Medium
Other Adverse Event Addition Operation 232
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/11/stats/3
Triage: Medium
Other Adverse Event Addition Operation 233
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 3
}
add /resultsSection/adverseEventsModule/otherEvents/11/stats/4
Triage: Medium
Other Adverse Event Addition Operation 234
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/11/stats/5
Triage: Medium
Other Adverse Event Addition Operation 235
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/12/term
Triage: Medium
Other Adverse Event Modification Operation 236
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Nausea
After
Creatinine Increased
replace /resultsSection/adverseEventsModule/otherEvents/12/organSystem
Triage: Medium
Other Adverse Event Modification Operation 237
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Gastrointestinal disorders
After
Investigations
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 238
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
8
After
3
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 239
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/12/stats/2
Triage: Medium
Other Adverse Event Addition Operation 240
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/12/stats/3
Triage: Medium
Other Adverse Event Addition Operation 241
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/12/stats/4
Triage: Medium
Other Adverse Event Addition Operation 242
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/12/stats/5
Triage: Medium
Other Adverse Event Addition Operation 243
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/13/term
Triage: Medium
Other Adverse Event Modification Operation 244
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Platelet Count Decreased
After
Dehydration
replace /resultsSection/adverseEventsModule/otherEvents/13/organSystem
Triage: Medium
Other Adverse Event Modification Operation 245
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Investigations
After
Metabolism and nutrition disorders
replace /resultsSection/adverseEventsModule/otherEvents/13/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 246
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/13/stats/2
Triage: Medium
Other Adverse Event Addition Operation 247
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/13/stats/3
Triage: Medium
Other Adverse Event Addition Operation 248
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/13/stats/4
Triage: Medium
Other Adverse Event Addition Operation 249
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/13/stats/5
Triage: Medium
Other Adverse Event Addition Operation 250
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/14/term
Triage: Medium
Other Adverse Event Modification Operation 251
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Serum Amylase Increased
After
Diarrhea
replace /resultsSection/adverseEventsModule/otherEvents/14/organSystem
Triage: Medium
Other Adverse Event Modification Operation 252
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Investigations
After
Gastrointestinal disorders
replace /resultsSection/adverseEventsModule/otherEvents/14/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 253
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
6
replace /resultsSection/adverseEventsModule/otherEvents/14/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 254
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/14/stats/2
Triage: Medium
Other Adverse Event Addition Operation 255
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/14/stats/3
Triage: Medium
Other Adverse Event Addition Operation 256
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/14/stats/4
Triage: Medium
Other Adverse Event Addition Operation 257
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/14/stats/5
Triage: Medium
Other Adverse Event Addition Operation 258
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/15/term
Triage: Medium
Other Adverse Event Modification Operation 259
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Vomiting
After
Dizziness
replace /resultsSection/adverseEventsModule/otherEvents/15/organSystem
Triage: Medium
Other Adverse Event Modification Operation 260
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Gastrointestinal disorders
After
Nervous system disorders
replace /resultsSection/adverseEventsModule/otherEvents/15/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 261
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
3
replace /resultsSection/adverseEventsModule/otherEvents/15/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 262
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
7
add /resultsSection/adverseEventsModule/otherEvents/15/stats/2
Triage: Medium
Other Adverse Event Addition Operation 263
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG002",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/15/stats/3
Triage: Medium
Other Adverse Event Addition Operation 264
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG003",
  "numAtRisk": 3,
  "numAffected": 3
}
add /resultsSection/adverseEventsModule/otherEvents/15/stats/4
Triage: Medium
Other Adverse Event Addition Operation 265
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/15/stats/5
Triage: Medium
Other Adverse Event Addition Operation 266
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 0
}
add /resultsSection/adverseEventsModule/otherEvents/16
Triage: Medium
Other Adverse Event Addition Operation 267
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Ear and Labyrinth Disorders - Ear drainage",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Ear and labyrinth disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/17
Triage: Medium
Other Adverse Event Addition Operation 268
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Edema Limbs",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "General disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/18
Triage: Medium
Other Adverse Event Addition Operation 269
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Erythema Multiforme",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Skin and subcutaneous tissue disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/19
Triage: Medium
Other Adverse Event Addition Operation 270
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Fall",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Injury, poisoning and procedural complications",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/20
Triage: Medium
Other Adverse Event Addition Operation 271
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Fatigue",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 6
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 3
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "General disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/21
Triage: Medium
Other Adverse Event Addition Operation 272
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Flu Like Symptoms",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "General disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/22
Triage: Medium
Other Adverse Event Addition Operation 273
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Headache",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 3
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Nervous system disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/23
Triage: Medium
Other Adverse Event Addition Operation 274
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Hematuria",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 2
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Renal and urinary disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/24
Triage: Medium
Other Adverse Event Addition Operation 275
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Hyperglycemia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Metabolism and nutrition disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/25
Triage: Medium
Other Adverse Event Addition Operation 276
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Hyperkalemia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Metabolism and nutrition disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/26
Triage: Medium
Other Adverse Event Addition Operation 277
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Hypoalbuminemia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 4
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Metabolism and nutrition disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/27
Triage: Medium
Other Adverse Event Addition Operation 278
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Hypocalcemia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 2
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Metabolism and nutrition disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/28
Triage: Medium
Other Adverse Event Addition Operation 279
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Hypoglycemia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Metabolism and nutrition disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/29
Triage: Medium
Other Adverse Event Addition Operation 280
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Hypokalemia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 2
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Metabolism and nutrition disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/30
Triage: Medium
Other Adverse Event Addition Operation 281
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Hypomagnesemia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 2
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Metabolism and nutrition disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/31
Triage: Medium
Other Adverse Event Addition Operation 282
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Hyponatremia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 2
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Metabolism and nutrition disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/32
Triage: Medium
Other Adverse Event Addition Operation 283
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Hypotension",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Vascular disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/33
Triage: Medium
Other Adverse Event Addition Operation 284
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Infections and Infestations - Streptococcal pharyngitis",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Infections and infestations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/34
Triage: Medium
Other Adverse Event Addition Operation 285
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Insomnia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Psychiatric disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/35
Triage: Medium
Other Adverse Event Addition Operation 286
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Irregular Menstruation",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Reproductive system and breast disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/36
Triage: Medium
Other Adverse Event Addition Operation 287
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Localized Edema",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "General disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/37
Triage: Medium
Other Adverse Event Addition Operation 288
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Lymphocyte Count Decreased",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Investigations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/38
Triage: Medium
Other Adverse Event Addition Operation 289
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Mucositis Oral",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 2
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Gastrointestinal disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/39
Triage: Medium
Other Adverse Event Addition Operation 290
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Muscle Cramp",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Musculoskeletal and connective tissue disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/40
Triage: Medium
Other Adverse Event Addition Operation 291
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Myalgia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 3
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Musculoskeletal and connective tissue disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/41
Triage: Medium
Other Adverse Event Addition Operation 292
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Nausea",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 6
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 2
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Gastrointestinal disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/42
Triage: Medium
Other Adverse Event Addition Operation 293
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Neutrophil Count Decreased",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Investigations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/43
Triage: Medium
Other Adverse Event Addition Operation 294
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Pain",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "General disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/44
Triage: Medium
Other Adverse Event Addition Operation 295
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Paresthesia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Nervous system disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/45
Triage: Medium
Other Adverse Event Addition Operation 296
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Paroxysmal Atrial Tachycardia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Cardiac disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/46
Triage: Medium
Other Adverse Event Addition Operation 297
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Platelet Count Decreased",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 3
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Investigations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/47
Triage: Medium
Other Adverse Event Addition Operation 298
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Pneumothorax",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Respiratory, thoracic and mediastinal disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/48
Triage: Medium
Other Adverse Event Addition Operation 299
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Productive Cough",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Respiratory, thoracic and mediastinal disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/49
Triage: Medium
Other Adverse Event Addition Operation 300
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Proteinuria",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Renal and urinary disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/50
Triage: Medium
Other Adverse Event Addition Operation 301
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Rash Acneiform",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Skin and subcutaneous tissue disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/51
Triage: Medium
Other Adverse Event Addition Operation 302
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Serum Amylase Increased",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 2
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 2
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Investigations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/52
Triage: Medium
Other Adverse Event Addition Operation 303
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Shingles",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Infections and infestations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/53
Triage: Medium
Other Adverse Event Addition Operation 304
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Sinus Bradycardia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 2
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Cardiac disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/54
Triage: Medium
Other Adverse Event Addition Operation 305
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Sinusitis",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Infections and infestations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/55
Triage: Medium
Other Adverse Event Addition Operation 306
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Skin and Subcutaneous Tissue Disorders - Skin lesion",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 2
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Skin and subcutaneous tissue disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/56
Triage: Medium
Other Adverse Event Addition Operation 307
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Skin Infection",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Infections and infestations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/57
Triage: Medium
Other Adverse Event Addition Operation 308
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Sore Throat",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Respiratory, thoracic and mediastinal disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/58
Triage: Medium
Other Adverse Event Addition Operation 309
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Upper Respiratory Infection",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Infections and infestations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/59
Triage: Medium
Other Adverse Event Addition Operation 310
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Urinary Frequency",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Renal and urinary disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/60
Triage: Medium
Other Adverse Event Addition Operation 311
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Urinary Tract Infection",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 2
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Infections and infestations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/61
Triage: Medium
Other Adverse Event Addition Operation 312
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Urinary Urgency",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Renal and urinary disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/62
Triage: Medium
Other Adverse Event Addition Operation 313
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Urine Discoloration",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Renal and urinary disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/63
Triage: Medium
Other Adverse Event Addition Operation 314
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Thromboembolic event",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Vascular disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/64
Triage: Medium
Other Adverse Event Addition Operation 315
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Vomiting",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 4
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 2
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Gastrointestinal disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/65
Triage: Medium
Other Adverse Event Addition Operation 316
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Watering Eyes",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 1
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Eye disorders",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/66
Triage: Medium
Other Adverse Event Addition Operation 317
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "Weight Loss",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 2
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Investigations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
add /resultsSection/adverseEventsModule/otherEvents/67
Triage: Medium
Other Adverse Event Addition Operation 318
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "term": "White Blood Cell Decreased",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 7,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 0
    }
  ],
  "organSystem": "Investigations",
  "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
remove /resultsSection/adverseEventsModule/armsReviewUnit
Triage: Uncategorized
Uncategorized Operation 319
Before
{
  "resetReasons": [
    "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
  ]
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 101 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2024-11
After
2025-02
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2025-01-28
After
2025-02-24
replace /resultsSection/participantFlowModule/groups/0/title
Triage: Uncategorized
Uncategorized Operation 3
Before
Phase Ib
After
Phase Ib: Dose Level 1
replace /resultsSection/participantFlowModule/groups/0/description
Triage: Uncategorized
Uncategorized Operation 4
Before
Dose Escalation of Neratinib with Capmatinib uses a 3+3 design.
Max 18 patients, treated in cohorts of 3, with safety data reviewed after each cohort's DLT period.
After
Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily
replace /resultsSection/participantFlowModule/groups/1/title
Triage: Uncategorized
Uncategorized Operation 5
Before
Phase II
After
Phase Ib: Dose Level 2
replace /resultsSection/participantFlowModule/groups/1/description
Triage: Uncategorized
Uncategorized Operation 6
Before
Subjects receive neratinib and capmatinib.
The MTD determined during Phase Ib will be used.
After
Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily"
add /resultsSection/participantFlowModule/groups/2
Triage: Uncategorized
Uncategorized Operation 7
After
{
  "id": "FG002",
  "title": "Phase Ib: Dose Level 3",
  "description": "Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily"
}
add /resultsSection/participantFlowModule/groups/3
Triage: Uncategorized
Uncategorized Operation 8
After
{
  "id": "FG003",
  "title": "Phase Ib: Dose Level-1",
  "description": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily"
}
add /resultsSection/participantFlowModule/groups/4
Triage: Uncategorized
Uncategorized Operation 9
After
{
  "id": "FG004",
  "title": "Phase Ib: Dose Level-2",
  "description": "Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily"
}
add /resultsSection/participantFlowModule/groups/5
Triage: Uncategorized
Uncategorized Operation 10
After
{
  "id": "FG005",
  "title": "Phase II",
  "description": "Subjects receive neratinib and capmatinib.\nThe MTD determined during Phase Ib will be used."
}
replace /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/0/numSubjects
Triage: Uncategorized
Uncategorized Operation 11
Before
10
After
7
add /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/2
Triage: Uncategorized
Uncategorized Operation 12
After
{
  "groupId": "FG002",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/3
Triage: Uncategorized
Uncategorized Operation 13
After
{
  "groupId": "FG003",
  "numSubjects": "3"
}
add /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/4
Triage: Uncategorized
Uncategorized Operation 14
After
{
  "groupId": "FG004",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/5
Triage: Uncategorized
Uncategorized Operation 15
After
{
  "groupId": "FG005",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/2
Triage: Uncategorized
Uncategorized Operation 16
After
{
  "groupId": "FG002",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/3
Triage: Uncategorized
Uncategorized Operation 17
After
{
  "groupId": "FG003",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/4
Triage: Uncategorized
Uncategorized Operation 18
After
{
  "groupId": "FG004",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/5
Triage: Uncategorized
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{
  "groupId": "FG005",
  "numSubjects": "0"
}
replace /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/0/numSubjects
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10
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7
add /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/2
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{
  "groupId": "FG002",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/3
Triage: Uncategorized
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After
{
  "groupId": "FG003",
  "numSubjects": "3"
}
add /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/4
Triage: Uncategorized
Uncategorized Operation 23
After
{
  "groupId": "FG004",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/5
Triage: Uncategorized
Uncategorized Operation 24
After
{
  "groupId": "FG005",
  "numSubjects": "0"
}
replace /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/0/numSubjects
Triage: Uncategorized
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4
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3
add /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/2
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After
{
  "groupId": "FG002",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/3
Triage: Uncategorized
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After
{
  "groupId": "FG003",
  "numSubjects": "1"
}
add /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/4
Triage: Uncategorized
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After
{
  "groupId": "FG004",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/5
Triage: Uncategorized
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{
  "groupId": "FG005",
  "numSubjects": "0"
}
replace /resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/0/numSubjects
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6
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4
add /resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/2
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{
  "groupId": "FG002",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/3
Triage: Uncategorized
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After
{
  "groupId": "FG003",
  "numSubjects": "2"
}
add /resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/4
Triage: Uncategorized
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After
{
  "groupId": "FG004",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/5
Triage: Uncategorized
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{
  "groupId": "FG005",
  "numSubjects": "0"
}
remove /resultsSection/participantFlowModule/periods/0/reviewUnit
Triage: Uncategorized
Uncategorized Operation 35
Before
{
  "resetReasons": [
    "The participant flow appears to include insufficient information to understand the arms/groups to which participants were assigned, the intervention strategy used in each arm/group, or how participants progressed in the study."
  ]
}
replace /resultsSection/baselineCharacteristicsModule/groups/0/title
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Before
Phase Ib
After
Phase Ib: Dose Level 1
replace /resultsSection/baselineCharacteristicsModule/groups/0/description
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Before
Dose Escalation of Neratinib with Capmatinib uses a 3+3 design.
Max 18 patients, treated in cohorts of 3, with safety data reviewed after each cohort's DLT period.
After
Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily
replace /resultsSection/baselineCharacteristicsModule/groups/1/title
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Before
Phase II
After
Phase Ib: Dose Level 2
replace /resultsSection/baselineCharacteristicsModule/groups/1/description
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Before
Subjects receive neratinib and capmatinib.
The MTD determined during Phase Ib will be used.
After
Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily
replace /resultsSection/baselineCharacteristicsModule/groups/2/title
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Before
Total
After
Phase Ib: Dose Level 3
replace /resultsSection/baselineCharacteristicsModule/groups/2/description
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Before
Total of all reporting groups
After
Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily
add /resultsSection/baselineCharacteristicsModule/groups/3
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After
{
  "id": "BG003",
  "title": "Phase Ib: Dose Level-1",
  "description": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily"
}
add /resultsSection/baselineCharacteristicsModule/groups/4
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{
  "id": "BG004",
  "title": "Phase Ib: Dose Level-2",
  "description": "Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily"
}
add /resultsSection/baselineCharacteristicsModule/groups/5
Triage: Uncategorized
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{
  "id": "BG005",
  "title": "Phase II",
  "description": "Subjects receive neratinib and capmatinib.\nThe MTD determined during Phase Ib will be used."
}
add /resultsSection/baselineCharacteristicsModule/groups/6
Triage: Uncategorized
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{
  "id": "BG006",
  "title": "Total",
  "description": "Total of all reporting groups"
}
replace /resultsSection/baselineCharacteristicsModule/denoms/0/counts/0/value
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10
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10
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0
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{
  "value": "3",
  "groupId": "BG003"
}
add /resultsSection/baselineCharacteristicsModule/denoms/0/counts/4
Triage: Uncategorized
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After
{
  "value": "0",
  "groupId": "BG004"
}
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{
  "value": "0",
  "groupId": "BG005"
}
add /resultsSection/baselineCharacteristicsModule/denoms/0/counts/6
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{
  "value": "10",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/0/value
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44.5
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46
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39
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37
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62
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50
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BG002
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BG003
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44.5
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39
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39
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34
add /resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/2
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{
  "value": "44.5",
  "groupId": "BG006",
  "lowerLimit": "39",
  "upperLimit": "62"
}
add /resultsSection/baselineCharacteristicsModule/measures/0/reviewUnit
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{
  "resetReasons": [
    "Information within the measure appears inconsistent."
  ]
}
replace /resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/0/measurements/0/value
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10
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7
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BG002
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BG003
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10
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3
add /resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/0/measurements/2
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{
  "value": "10",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/1/measurements/1/groupId
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BG002
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BG003
add /resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/1/measurements/2
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{
  "value": "0",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/0/value
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2
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1
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BG002
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BG003
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2
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1
add /resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/2
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{
  "value": "2",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/1/measurements/0/value
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8
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6
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BG002
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BG003
replace /resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/1/measurements/1/value
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Before
8
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2
add /resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/1/measurements/2
Triage: Uncategorized
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{
  "value": "8",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/2/measurements/1/groupId
Triage: Uncategorized
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BG002
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BG003
add /resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/2/measurements/2
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{
  "value": "0",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/0/measurements/1/groupId
Triage: Uncategorized
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BG002
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BG003
add /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/0/measurements/2
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{
  "value": "0",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/1/measurements/1/groupId
Triage: Uncategorized
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BG002
After
BG003
add /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/1/measurements/2
Triage: Uncategorized
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After
{
  "value": "0",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/2/measurements/1/groupId
Triage: Uncategorized
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BG002
After
BG003
add /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/2/measurements/2
Triage: Uncategorized
Uncategorized Operation 81
After
{
  "value": "0",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/3/measurements/0/value
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4
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3
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BG002
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BG003
replace /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/3/measurements/1/value
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4
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1
add /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/3/measurements/2
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{
  "value": "4",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/4/measurements/0/value
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5
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4
replace /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/4/measurements/1/groupId
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BG002
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BG003
replace /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/4/measurements/1/value
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Before
5
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1
add /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/4/measurements/2
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After
{
  "value": "5",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/5/measurements/0/value
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Before
1
After
0
replace /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/5/measurements/1/groupId
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BG002
After
BG003
add /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/5/measurements/2
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{
  "value": "1",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/6/measurements/1/groupId
Triage: Uncategorized
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BG002
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BG003
add /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/6/measurements/2
Triage: Uncategorized
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After
{
  "value": "0",
  "groupId": "BG006"
}
replace /resultsSection/baselineCharacteristicsModule/measures/4/classes/0/categories/0/measurements/0/value
Triage: Uncategorized
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10
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7
replace /resultsSection/baselineCharacteristicsModule/measures/4/classes/0/categories/0/measurements/1/groupId
Triage: Uncategorized
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Before
BG002
After
BG003
replace /resultsSection/baselineCharacteristicsModule/measures/4/classes/0/categories/0/measurements/1/value
Triage: Uncategorized
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10
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3
add /resultsSection/baselineCharacteristicsModule/measures/4/classes/0/categories/0/measurements/2
Triage: Uncategorized
Uncategorized Operation 98
After
{
  "value": "10",
  "groupId": "BG006"
}
remove /resultsSection/baselineCharacteristicsModule/reviewUnit
Triage: Uncategorized
Uncategorized Operation 99
Before
{
  "resetReasons": [
    "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
  ]
}
replace /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
Triage: Uncategorized
Uncategorized Operation 320
Before
2025-02-19
After
2025-03-11
add /reviewUnit
Triage: Uncategorized
Uncategorized Operation 321
After
{
  "resetReasons": [
    "Issues noted on a previous submission of this record do not appear to have been addressed."
  ]
}
Results outcome measures Posted result outcome measures and result-level endpoint data. Triage: Uncategorized 7 ops
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/paramType
Triage: Uncategorized
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Before
COUNT_OF_PARTICIPANTS
After
NUMBER
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/unitOfMeasure
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Uncategorized Operation 101
Before
Participants
After
Dose level (mg)
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/description
Triage: Uncategorized
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Before
Dose Escalation of Neratinib with Capmatinib uses a 3+3 design.
Max 18 patients, treated in cohorts of 3, with safety data reviewed after each cohort's DLT period.
After
All participants who received Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily or Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/value
Triage: Uncategorized
Uncategorized Operation 103
Before
9
After
NA
add /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/comment
Triage: Uncategorized
Uncategorized Operation 104
After
No MTD was determined since the study was terminated prematurely during phase Ib.
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/measureCategoriesReviewUnit
Triage: Uncategorized
Uncategorized Operation 105
Before
{
  "resetReasons": [
    "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
  ]
}
add /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/populationDescription
Triage: Uncategorized
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After
Baseline analysis population included all participants treated.
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2025-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2025-02-24"
  },
  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/groups/0/title",
    "value": "Phase Ib: Dose Level 1"
  },
  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/groups/0/description",
    "value": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily"
  },
  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/groups/1/title",
    "value": "Phase Ib: Dose Level 2"
  },
  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/groups/1/description",
    "value": "Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily""
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/groups/2",
    "value": {
      "id": "FG002",
      "title": "Phase Ib: Dose Level 3",
      "description": "Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/groups/3",
    "value": {
      "id": "FG003",
      "title": "Phase Ib: Dose Level-1",
      "description": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/groups/4",
    "value": {
      "id": "FG004",
      "title": "Phase Ib: Dose Level-2",
      "description": "Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/groups/5",
    "value": {
      "id": "FG005",
      "title": "Phase II",
      "description": "Subjects receive neratinib and capmatinib.\nThe MTD determined during Phase Ib will be used."
    }
  },
  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/0/numSubjects",
    "value": "7"
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/2",
    "value": {
      "groupId": "FG002",
      "numSubjects": "0"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/3",
    "value": {
      "groupId": "FG003",
      "numSubjects": "3"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/4",
    "value": {
      "groupId": "FG004",
      "numSubjects": "0"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/5",
    "value": {
      "groupId": "FG005",
      "numSubjects": "0"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/2",
    "value": {
      "groupId": "FG002",
      "numSubjects": "0"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/3",
    "value": {
      "groupId": "FG003",
      "numSubjects": "0"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/4",
    "value": {
      "groupId": "FG004",
      "numSubjects": "0"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/5",
    "value": {
      "groupId": "FG005",
      "numSubjects": "0"
    }
  },
  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/0/numSubjects",
    "value": "7"
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/2",
    "value": {
      "groupId": "FG002",
      "numSubjects": "0"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/3",
    "value": {
      "groupId": "FG003",
      "numSubjects": "3"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/4",
    "value": {
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    "path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/0/numAtRisk",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/0/stats/0/numAtRisk",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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      "groupId": "EG005",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/1/stats/0/numAffected",
    "value": 3
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/1/stats/0/numAtRisk",
    "value": 7
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  {
    "op": "add",
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      "groupId": "EG002",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/2/term",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/2/organSystem",
    "value": "Investigations"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/2/stats/0/numAffected",
    "value": 1
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/2/stats/0/numAtRisk",
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  {
    "op": "add",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/3/term",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/3/organSystem",
    "value": "Blood and lymphatic system disorders"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/3/stats/0/numAffected",
    "value": 1
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/3/stats/0/numAtRisk",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/4/term",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/4/organSystem",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/4/stats/0/numAffected",
    "value": 3
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/4/stats/0/numAtRisk",
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    "op": "add",
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    "op": "add",
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    "op": "add",
    "path": "/resultsSection/adverseEventsModule/otherEvents/4/stats/4",
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      "groupId": "EG004",
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    "op": "add",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/5/term",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/5/organSystem",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/5/stats/0/numAffected",
    "value": 3
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/5/stats/0/numAtRisk",
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    "op": "add",
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    "op": "add",
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  {
    "op": "add",
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    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/6/term",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/6/organSystem",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/6/stats/0/numAffected",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/6/stats/0/numAtRisk",
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    "op": "add",
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    "op": "add",
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    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/7/term",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/7/organSystem",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/7/stats/0/numAffected",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/7/stats/0/numAtRisk",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/8/term",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/8/organSystem",
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    "op": "replace",
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    "op": "replace",
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    "op": "add",
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    "op": "replace",
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    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/9/organSystem",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/9/stats/0/numAffected",
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    "op": "replace",
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    "op": "add",
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    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/10/term",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/10/organSystem",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/10/stats/0/numAffected",
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    "op": "replace",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/11/term",
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    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/11/organSystem",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/11/stats/0/numAffected",
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  {
    "op": "replace",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/12/term",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/12/organSystem",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/12/stats/0/numAffected",
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    "op": "replace",
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    "op": "add",
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  {
    "op": "add",
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    "op": "add",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/13/term",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/13/organSystem",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/13/stats/0/numAtRisk",
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  {
    "op": "add",
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  {
    "op": "add",
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  {
    "op": "add",
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  {
    "op": "add",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/14/term",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/14/organSystem",
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/14/stats/0/numAffected",
    "value": 6
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/14/stats/0/numAtRisk",
    "value": 7
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  {
    "op": "add",
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  {
    "op": "add",
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  },
  {
    "op": "add",
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  {
    "op": "add",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/15/term",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/15/organSystem",
    "value": "Nervous system disorders"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/15/stats/0/numAffected",
    "value": 3
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  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/15/stats/0/numAtRisk",
    "value": 7
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  {
    "op": "add",
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  {
    "op": "add",
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  },
  {
    "op": "add",
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  {
    "op": "add",
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      "groupId": "EG005",
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  {
    "op": "add",
    "path": "/resultsSection/adverseEventsModule/otherEvents/16",
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      "term": "Ear and Labyrinth Disorders - Ear drainage",
      "stats": [
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          "groupId": "EG000",
          "numAtRisk": 7,
          "numAffected": 1
        },
        {
          "groupId": "EG001",
          "numAtRisk": 0
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        {
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    "op": "add",
    "path": "/resultsSection/adverseEventsModule/otherEvents/17",
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      "term": "Edema Limbs",
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    "op": "add",
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    "op": "add",
    "path": "/resultsSection/adverseEventsModule/otherEvents/19",
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    "op": "add",
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    "op": "add",
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]