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 @ 7:16 PM
Ignite Modification Date: 2025-12-25 @ 4:53 PM
NCT ID: NCT00867503
Description: None
Frequency Threshold: 5
Time Frame: Life of study
Study: NCT00867503
Study Brief: Open Trial of Bendamustine Hydrochloride in Women With Advanced 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
Bendamustine bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2. None None 2 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Small Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Rigors SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Weight Loss SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Anoxeria SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Distention SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Oral Mucositis SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Other GI SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neutrophils SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Muscle weakness/ Cramping SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Sensory Neuropathy SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain Abdominal, chest, back SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
COugh/Dyspnea SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dehydration SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Platlets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hypoantremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View