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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:44 PM
NCT ID: NCT02921269
Description: None
Frequency Threshold: 5
Time Frame: Up to 30 days after the last dose of study treatment, on average of 4 months.
Study: NCT02921269
Study Brief: Atezolizumab and Bevacizumab in Treating Patients With Recurrent, Persistent, or Metastatic Cervical 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
Treatment (Atezolizumab, Bevacizumab) Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Bevacizumab: Given IV Laboratory Biomarker Analysis: Correlative studies 11 None 0 11 11 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thromboembolic event NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalagia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Arachnoiditis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sensorineural hearing loss NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Meningitis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View