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 @ 12:42 PM
Ignite Modification Date: 2025-12-25 @ 12:13 PM
NCT ID: NCT00604461
Description: None
Frequency Threshold: 0
Time Frame: 2 Years, 9 MOnths
Study: NCT00604461
Study Brief: Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma (MPM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dose Escalation Followed by Maintenance Therapy A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first. None None 4 13 13 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE V3 View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE V3 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE V3 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE V3 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE V3 View
Thromboembolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE V3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE V3 View
Anorexia SYSTEMATIC_ASSESSMENT General disorders CTCAE V3 View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE V3 View
Constipation/Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE V3 View
Dysgeusia SYSTEMATIC_ASSESSMENT General disorders CTCAE V3 View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE V3 View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders CTCAE V3 View
Fatigue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE V3 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE V3 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE V3 View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE V3 View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE V3 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE V3 View
Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE V3 View
Transaminitis SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE V3 View