NCT03094169
Version 10 to 11 · Formation Biologics
Patch inspector
Manual review pending.
None recorded.
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"signal": "results_reconciliation_outcome_suppression",
"category": "results_reconciliation",
"severity": "low"
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] bac72d90a4f2cd61b39b17504ff128c78f05ab092e48106b7dcf9a85de0eff8a/protocolSection/outcomesModule/primaryOutcomes/0/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Phase 1a: Determine safety and tolerability of AVID100
Phase 1a: Determine Safety and Tolerability of AVID100
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. 6 months
Overall study timeframe
/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. {
"resetReasons": [
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} /protocolSection/outcomesModule/primaryOutcomes/1/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Phase 2a: Evaluation of the preliminary antineoplastic effects of AVID100
Phase 2a: Evaluation of the Preliminary Antineoplastic Effects of AVID100
/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. 18 months
Overall Study
/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. {
"resetReasons": [
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} /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 18 months
Not Completed
/protocolSection/statusModule/lastUpdateSubmitDate 2021-03-22
2021-09-10
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2021-03-24
2021-10-07
/protocolSection/statusModule/resultsFirstSubmitDate 2021-09-10
/hasResults false
true
/resultsSection {
"moreInfoModule": {
"pointOfContact": {
"email": "sandra@forbius.com",
"phone": "8326221699",
"title": "Sandra Sinclair",
"organization": "Formation Biologics"
},
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"timeFrame": "Overall Study",
"reviewUnit": {
"resetReasons": [
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},
"eventGroups": [
{
"id": "EG000",
"title": "Dose Escalation",
"description": "<p>Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>",
"otherNumAtRisk": 24,
"deathsNumAtRisk": 24,
"otherNumAffected": 23,
"seriousNumAtRisk": 24,
"deathsNumAffected": 1,
"seriousNumAffected": 8
},
{
"id": "EG001",
"title": "Phase 2a Triple Negative Breast Cancer",
"description": "<p>Addition of up to 15 patients in each of 2 subpopulations of patients with triple negative breast cancer (30 total).\nOne group of 15 patients will have 3+ EGFR over-expression.\nThe second group will have 2+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>",
"otherNumAtRisk": 6,
"deathsNumAtRisk": 6,
"otherNumAffected": 6,
"seriousNumAtRisk": 6,
"deathsNumAffected": 2,
"seriousNumAffected": 3
},
{
"id": "EG002",
"title": "Phase 2a Head and Neck Carcinoma",
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"otherNumAtRisk": 15,
"deathsNumAtRisk": 15,
"otherNumAffected": 15,
"seriousNumAtRisk": 15,
"deathsNumAffected": 0,
"seriousNumAffected": 9
},
{
"id": "EG003",
"title": "Phase 2a Non-Small Cell Lung Carcinoma",
"description": "<p>Addition of 15 patients with squamous histology non-small cell lung carcinoma.\nPatients will have 3+ EGFR over-expression</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>",
"otherNumAtRisk": 3,
"deathsNumAtRisk": 3,
"otherNumAffected": 3,
"seriousNumAtRisk": 3,
"deathsNumAffected": 0,
"seriousNumAffected": 1
}
],
"otherEvents": [
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 11,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG002",
"numAtRisk": 15,
"numEvents": 6,
"numAffected": 6
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Viral Upper Respiratory Tract Infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 15,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
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}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Dyspnoea",
"stats": [
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"numEvents": 2,
"numAffected": 2
},
{
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},
{
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},
{
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"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Dry Eye",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 15,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Dehydration",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 15,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Cystitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 0,
"numAffected": 0
},
{
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"numEvents": 0,
"numAffected": 0
},
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"groupId": "EG003",
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"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Conjunctivitis Allergic",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 0,
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},
{
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},
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"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Blood Bilirubin Increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
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},
{
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},
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}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Tumour Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 1,
"numAffected": 1
},
{
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"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
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}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Lymphocyte Count Decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 6,
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},
{
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"numAffected": 2
},
{
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"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Keratitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 15,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Dry Skin",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 15,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 1,
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},
{
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},
{
"groupId": "EG003",
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"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Blood Alkaline Phosphate Increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 6,
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"numAffected": 0
},
{
"groupId": "EG002",
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},
{
"groupId": "EG003",
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"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Nasal Congestion",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 6,
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},
{
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},
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}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Lipase Increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 15,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 3,
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"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 6,
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"numAffected": 1
},
{
"groupId": "EG002",
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},
{
"groupId": "EG003",
"numAtRisk": 3,
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}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Diarrhoea",
"stats": [
{
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"numAtRisk": 24,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 6,
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},
{
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"numEvents": 1,
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},
{
"groupId": "EG003",
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}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 6,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
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"numAffected": 2
},
{
"groupId": "EG003",
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"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Aspartate Aminotransferase Increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 6,
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},
{
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},
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}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Rash Maculopapular",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 5,
"numAffected": 5
},
{
"groupId": "EG001",
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{
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{
"groupId": "EG003",
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}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Platelet Count Decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
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},
{
"groupId": "EG001",
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},
{
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},
{
"groupId": "EG003",
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}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Infusion Related Reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
"numEvents": 4,
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},
{
"groupId": "EG001",
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},
{
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},
{
"groupId": "EG003",
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}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Decreased Appetite",
"stats": [
{
"groupId": "EG000",
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},
{
"groupId": "EG001",
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{
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},
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}
],
"organSystem": "Metabolism and nutrition disorders",
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},
{
"term": "Abdominal Pain",
"stats": [
{
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},
{
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},
{
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},
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}
],
"organSystem": "Gastrointestinal disorders",
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},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
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"numEvents": 7,
"numAffected": 7
},
{
"groupId": "EG001",
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"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG002",
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"numAffected": 0
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{
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"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Hypokalaemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
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"numAffected": 7
},
{
"groupId": "EG001",
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"numAffected": 1
},
{
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},
{
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"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 22.0"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 24,
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"numAffected": 9
},
{
"groupId": "EG001",
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},
{
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},
{
"groupId": "EG003",
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"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Dermatitis Acneform",
"stats": [
{
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},
{
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{
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},
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{
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