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 @ 4:54 PM
Ignite Modification Date: 2025-12-25 @ 2:37 PM
NCT ID: NCT00655850
Description: None
Frequency Threshold: 5
Time Frame: Baseline up to 24 months
Study: NCT00655850
Study Brief: Lower Dose Chemotherapy Given More Frequent With Avastin to Treat Advanced Non-Squamous Non-Small Cell Lung 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
Paclitaxel and Gemcitabine + Avastin Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent. 2 None 25 36 36 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fatigue: Induction SYSTEMATIC_ASSESSMENT General disorders None View
Nausea Vomiting: Induction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension Grade: end of Cycle 1 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension: end of induction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension grade: maintenance SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Proteinuria: Induction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria: Maintenance SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Neutropenia: Induction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia: Induction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia: Induction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia: Induction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea/Vomiting: Induction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea: Induction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue: Induction SYSTEMATIC_ASSESSMENT General disorders None View
Neuropathy: Induction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension grade: end of Cycle 1 SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension grade: end of induction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension grade: maintenance SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Proteinuria: Induction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria: Maintenance SYSTEMATIC_ASSESSMENT Cardiac disorders None View