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 @ 6:32 PM
Ignite Modification Date: 2025-12-25 @ 4:02 PM
NCT ID: NCT02569957
Description: None
Frequency Threshold: 0
Time Frame: 8 months
Study: NCT02569957
Study Brief: Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube 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
Arm I (Topotecan Hydrochloride) Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Topotecan Hydrochloride: Given IV None None 0 0 0 0 View
Arm II (Topotecan Hydrochloride, Acetylcysteine) Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Topotecan Hydrochloride: Given IV Acetylcysteine: Given IV and PO None None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Activated Partial Thromboplastin Time prolonged NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ANC decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatine Increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elevated WBC urine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Gastrointestinal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
INR increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphocyte Count Decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Musculoskeletal and Connective Tissue disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Non-cardiac Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Platelet Count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Presyncope NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Skin Biopsy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Tearing NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
UTI NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vaginal Spotting NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Right side chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View