Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT00826150
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were assessed over a 16 week period, starting with each participant's first treatment with IP.
Study: NCT00826150
Study Brief: Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BC-819 60 mg IP 60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. 3 None 6 8 8 8 View
BC-819 120 mg IP 120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. 0 None 1 3 3 3 View
BC-819 240 mg IP 120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. 0 None 0 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Elevated liver enzymes NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Clinical deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Recurrent urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Weakness and shortness of breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Infection of port NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Chest pain and dyspnea NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Investigations NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hedache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Renal and urinary disorders NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Vascular disorders NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood albumin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood calcium decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood potassium increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Cardiac disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Gastrointestinal disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
General disorders and administration site conditions NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Injury, poisoning and procedural complications NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View