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 @ 4:41 PM
Ignite Modification Date: 2025-12-25 @ 2:29 PM
NCT ID: NCT00998166
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00998166
Study Brief: A Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pemetrexed, Cisplatin, Bevacizumab Chemotherapy infusion on Day 1 of a 3-week cycle Pemetrexed: 1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour Cisplatin: 4. Cisplatin 75mg/m2 IV over 60-120 minutes Bevacizumab: 5. Bevacizumab 15mg/kg IV over 90 minutes 0 None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated Creatinine None General disorders None View
Diarrhea None Gastrointestinal disorders None View
Back Pain None General disorders None View
Constipation None Gastrointestinal disorders None View
Chest Pain None General disorders None View
Pain None General disorders None View
Headache None General disorders None View
Nausea None Gastrointestinal disorders None View
Fatigue None General disorders None View
Flank Pain None General disorders None View
Thrombotic Microangiopathy None Blood and lymphatic system disorders None View
Abdominal Pain None General disorders None View
Allergic Reaction None Immune system disorders None View
Cystitis None Renal and urinary disorders None View
Pruritis None General disorders None View
Hypertension None Cardiac disorders None View
Hoarseness None General disorders None View
Anorexia None Gastrointestinal disorders None View
Epistaxis None General disorders None View
Anxiety None Psychiatric disorders None View
Anemia None Blood and lymphatic system disorders None View
Hypocalcemia None Blood and lymphatic system disorders None View
Sore throat None General disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Epigastric Discomfort None Gastrointestinal disorders None View
Cough None General disorders None View
Hypokalemia None Blood and lymphatic system disorders None View
Increased Blood Urea Nitrogen None Blood and lymphatic system disorders None View
Urinary Tract Infection None Renal and urinary disorders None View
Left calf cramps None Musculoskeletal and connective tissue disorders None View
Tinnitus None Ear and labyrinth disorders None View
Vasovagal Reaction None General disorders None View
Taste Alteration None General disorders None View
Hyponatremia None Blood and lymphatic system disorders None View
Hypomagnesemia None Blood and lymphatic system disorders None View
Hypoglycemia None Blood and lymphatic system disorders None View
Periorbital edema None Eye disorders None View
Increased Nasal Mucus None General disorders None View
Vomiting None Gastrointestinal disorders None View
Runny Nose None General disorders None View
Conjunctivitis None Eye disorders None View
Skin Tears None Skin and subcutaneous tissue disorders None View
Weight Loss None General disorders None View