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: 2025-12-25 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT02967133
Description: None
Frequency Threshold: 0
Time Frame: 13 months
Study: NCT02967133
Study Brief: A Study of Nivolumab +/- Nab-paclitaxel in 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
Arm A (Nivolumab Alone) Nivolumab q 14 days until disease progression/toxicity Nivolumab: Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated. 0 None 0 3 3 3 View
Arm B (Nivolumab + Nab-Paclitaxel) Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days nab-paclitaxel: Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle. 1 None 1 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NOS SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastrointestinal disorders - Oth spec SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Gen disord and admin site conds-Oth spec SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Resp, thoracic, mediastinal - Oth spec SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View
Vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View