NCT03735680
Version 9 to 10 · OncoNano Medicine, Inc.
Patch inspector
Manual review pending.
adverse_event_group_changeserious_adverse_event_modification [
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"resetReasons": [
"More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent."
]
} /resultsSection/adverseEventsModule/timeFrame Adverse events were collected from the time of study drug administration throughout the course of the study. The total collection period for each subject was approximately one month.
Safety results are available for all 30 patients enrolled in Part 1 (n=9 patients), Part 2 (n=10 patients) and Part 3 (n=11 patients). All patients enrolled in this study received a single dose of ONM-100. The total collection period for each subject was approximately one month.
/resultsSection/adverseEventsModule/eventGroups/0/description adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority. <p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to an ICG-like moiety.</p>
Overall treatment-emergent adverse events reported in patients receiving ONM-100.
/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority. 30
0
/resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority. 30
26
/resultsSection/adverseEventsModule/seriousEvents/0/organSystem serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority. Skin and subcutaneous tissue disorders
Infections and infestations
/resultsSection/adverseEventsModule/seriousEvents/0/assessmentType serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority. NON_SYSTEMATIC_ASSESSMENT
SYSTEMATIC_ASSESSMENT
/resultsSection/adverseEventsModule/seriousEvents/1/term serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority. Superficial Vein Thrombosis
Abscess neck
/resultsSection/adverseEventsModule/seriousEvents/1/organSystem serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority. Vascular disorders
Infections and infestations
/resultsSection/adverseEventsModule/seriousEvents/2/term serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority. Abscess Neck
Tonsillar hemorrhage
/resultsSection/adverseEventsModule/seriousEvents/2/organSystem serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority. Skin and subcutaneous tissue disorders
Respiratory, thoracic and mediastinal disorders
/resultsSection/adverseEventsModule/seriousEvents/4/term serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority. Tonsillar Hemorrhage
Superficial vein thrombosis
/resultsSection/adverseEventsModule/seriousEvents/4/organSystem serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority. Respiratory, thoracic and mediastinal disorders
Vascular disorders
/resultsSection/adverseEventsModule/seriousEvents/5/term serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority. Infusion Related Reaction
Infusion related reaction
/resultsSection/adverseEventsModule/description No adverse events leading to death were reported.
/resultsSection/adverseEventsModule/reviewUnit {
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]
} /protocolSection/outcomesModule/secondaryOutcomes/0/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging at doses of 1 mg/kg, 2 mg/kg and 3 mg/kg.
/protocolSection/outcomesModule/secondaryOutcomes/2/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses.
/protocolSection/statusModule/statusVerifiedDate 2022-02
2023-04
/protocolSection/statusModule/lastUpdateSubmitDate 2023-01-16
2023-04-19
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2023-02-13
2023-05-12
/resultsSection/participantFlowModule/groups/0/title Patients Receiving ONM-100
Part 1, Cohort A
/resultsSection/participantFlowModule/groups/0/description <p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to IGC.</p>
Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.
/resultsSection/participantFlowModule/groups/1 {
"id": "FG001",
"title": "Part 1, Cohort B",
"description": "Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg for safety evaluation and surgery and imaging at 3 ±2 hours post dose."
} /resultsSection/participantFlowModule/groups/2 {
"id": "FG002",
"title": "Part 1, Cohort E",
"description": "Patients were administered a single dose of pegsitacianine (ONM-100) 2 mg/kg and evaluated whether alternate imaging schedules post dose (ie, other than 3 ±2 hours post dose) provided acceptable imaging results at doses ≤3 mg/kg."
} /resultsSection/participantFlowModule/groups/3 {
"id": "FG003",
"title": "Part 2, Group 2",
"description": "Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg.\nSurgery/imaging time hours to be determined (TBD)."
} /resultsSection/participantFlowModule/groups/4 {
"id": "FG004",
"title": "Part 2, Group 3",
"description": "Patients were administered a single dose of pegsitacianine (ONM-100) at 1.0 mg/kg.\nSurgery/imaging time, hours 16-80."
} /resultsSection/participantFlowModule/groups/5 {
"id": "FG005",
"title": "Part 3",
"description": "Patients received a single dose of pegsitacianine (ONM-100) at 1 mg/kg administered at 24 ±8 hours prior to surgery."
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"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."
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} /resultsSection/baselineCharacteristicsModule/groups/0/title Patients Receiving ONM-100
Part 1, Cohort A
/resultsSection/baselineCharacteristicsModule/groups/0/description <p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to an ICG-like moiety.</p>
Patients were administered a single dose of pegsitacianine (ONM-100) at 1.0 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.
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"description": "Patients were administered a single dose of pegsitacianine (ONM-100) at 3.0 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose."
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"id": "BG003",
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} /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/6/measurements/4 {
"value": "0",
"groupId": "BG004"
} /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/6/measurements/5 {
"value": "2",
"groupId": "BG005"
} /resultsSection/baselineCharacteristicsModule/measures/3/classes/0/categories/6/measurements/6 {
"value": "2",
"groupId": "BG006"
} /resultsSection/baselineCharacteristicsModule/measures/4/classes/0/categories/0/measurements/0/value 30
3
/resultsSection/baselineCharacteristicsModule/measures/4/classes/0/categories/0/measurements/1 {
"value": "3",
"groupId": "BG001"
} /resultsSection/baselineCharacteristicsModule/measures/4/classes/0/categories/0/measurements/2 {
"value": "3",
"groupId": "BG002"
} /resultsSection/baselineCharacteristicsModule/measures/4/classes/0/categories/0/measurements/3 {
"value": "4",
"groupId": "BG003"
} /resultsSection/baselineCharacteristicsModule/measures/4/classes/0/categories/0/measurements/4 {
"value": "6",
"groupId": "BG004"
} /resultsSection/baselineCharacteristicsModule/measures/4/classes/0/categories/0/measurements/5 {
"value": "11",
"groupId": "BG005"
} /resultsSection/baselineCharacteristicsModule/measures/4/classes/0/categories/0/measurements/6 {
"value": "30",
"groupId": "BG006"
} /resultsSection/baselineCharacteristicsModule/measures/5/title Patients receiving ONM-100
Patients receiving pegsitacianine (ONM-100)
/resultsSection/baselineCharacteristicsModule/measures/5/classes/0/categories/0/measurements/0/value 30
3
/resultsSection/baselineCharacteristicsModule/measures/5/classes/0/categories/0/measurements/1 {
"value": "3",
"groupId": "BG001"
} /resultsSection/baselineCharacteristicsModule/measures/5/classes/0/categories/0/measurements/2 {
"value": "3",
"groupId": "BG002"
} /resultsSection/baselineCharacteristicsModule/measures/5/classes/0/categories/0/measurements/3 {
"value": "4",
"groupId": "BG003"
} /resultsSection/baselineCharacteristicsModule/measures/5/classes/0/categories/0/measurements/4 {
"value": "6",
"groupId": "BG004"
} /resultsSection/baselineCharacteristicsModule/measures/5/classes/0/categories/0/measurements/5 {
"value": "11",
"groupId": "BG005"
} /resultsSection/baselineCharacteristicsModule/measures/5/classes/0/categories/0/measurements/6 {
"value": "30",
"groupId": "BG006"
} /resultsSection/baselineCharacteristicsModule/reviewUnit {
"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."
]
} /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date 2023-02-10
2023-05-11
/reviewUnit {
"resetReasons": [
"Issues noted on a previous submission of this record do not appear to have been addressed."
]
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/title ONM-100 at a Dose of 1 mg/kg
Part 1, Cohort A
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/description All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/1/title ONM-100 at a Dose of 3 mg/kg
Part 1, Cohort B
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/2/title ONM-100 at a Dose of 2 mg/kg
Part 1, Cohort E
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/3 {
"id": "OG003",
"title": "Part 2, Group 2",
"description": "All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg."
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/4 {
"id": "OG004",
"title": "Part 2, Group 3",
"description": "All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg."
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/5 {
"id": "OG005",
"title": "Part 3",
"description": "All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg."
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms/0/counts/0/value 3
1
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms/0/counts/2/value 2
3
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms/0/counts/3 {
"value": "4",
"groupId": "OG003"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms/0/counts/4 {
"value": "6",
"groupId": "OG004"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms/0/counts/5 {
"value": "11",
"groupId": "OG005"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/value 2.858
1.098
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/spread 2.2128
0
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/value 3.498
4.022
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/spread 1.3717
2.8139
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/2/value 2.608
2.280
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/2/spread 2.5936
1.6393
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/3 {
"value": "4.110",
"spread": "1.2527",
"groupId": "OG003"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/4 {
"value": "3.007",
"spread": "1.3822",
"groupId": "OG004"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/5 {
"value": "2.608",
"spread": "2.5936",
"groupId": "OG005"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit {
"resetReasons": [
"More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent."
]
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/title Patients Receiving ONM-100
Part 1, Cohort A
/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/description <p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to IGC.</p>
Patients were administered a single IV infusion of ONM-100 at a dose of 1 mg/kg.
/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1 {
"id": "OG001",
"title": "Part 1, Cohort B",
"description": "Patients were administered a single IV infusion of OMN-100 at a dose of 3 mg/kg."
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/2 {
"id": "OG002",
"title": "Part 1, Cohort E",
"description": "Patients were administered a single IV infusion of OMN-100 at a dose of 2 mg/kg."
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/3 {
"id": "OG003",
"title": "Part 2, Group 2",
"description": "Patients were administered a single IV infusion of ONM-100 at a dose of 3 mg/kg."
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/4 {
"id": "OG004",
"title": "Part 2, Group 3",
"description": "Patients were administered a single IV infusion of ONM-100 at a dose of 1 mg/kg."
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/5 {
"id": "OG005",
"title": "Part 3",
"description": "Patients were administered a single IV infusion of ONM-100 at a dose of 1 mg/kg."
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/0/value 30
3
/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/1 {
"value": "3",
"groupId": "OG001"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/2 {
"value": "3",
"groupId": "OG002"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/3 {
"value": "4",
"groupId": "OG003"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/4 {
"value": "6",
"groupId": "OG004"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/5 {
"value": "11",
"groupId": "OG005"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/value 26
2
/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1 {
"value": "3",
"groupId": "OG001"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/2 {
"value": "2",
"groupId": "OG002"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/3 {
"value": "4",
"groupId": "OG003"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/4 {
"value": "6",
"groupId": "OG004"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/5 {
"value": "9",
"groupId": "OG005"
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit {
"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."
]
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging at doses of 1 mg/kg, 2 mg/kg and 3 mg/kg.
/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/title ONM-100 at a Dose of 1 mg/kg
Patients Receiving ONM-100 a Dose of 1 mg/kg
/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/description All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
All patients in the study who received a single IV administration of ONM-100 at 1 mg/kg.
/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/1/title ONM-100 at a Dose of 2 mg/kg
Patients Receiving ONM-100 at a Dose of 2 mg/kg
/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/1/description All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.
All patients in the study who received a single IV administration of ONM-100 at 2 mg/kg.
/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/2/title ONM-100 at a Dose of 3 mg/kg
Patients Receiving ONM-100 at a Dose of 3 mg/kg
/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/2/description All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.
All patients in the study who received a single IV administration of ONM-100 at 3 mg/kg.
/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/measureCategoriesReviewUnit {
"resetReasons": [
"The number of participants appears inconsistent with the number of participants enrolled in the study."
]
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit {
"resetReasons": [
"The number of participants appears inconsistent with the number of participants enrolled in the study."
]
} /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses.
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}
},
{
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}
},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
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},
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},
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{
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},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/title",
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},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/description",
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},
{
"op": "replace",
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{
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},
{
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{
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}
},
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}
},
{
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/timeFrame",
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},
{
"op": "replace",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/0/assessmentType",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/term",
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{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/1/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/term",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/2/organSystem",
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},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/term",
"value": "Superficial vein thrombosis"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/4/organSystem",
"value": "Vascular disorders"
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/seriousEvents/5/term",
"value": "Infusion related reaction"
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{
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},
{
"op": "add",
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}
},
{
"op": "add",
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}
},
{
"op": "replace",
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}
]