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 @ 4:08 AM
Ignite Modification Date: 2025-12-26 @ 3:05 AM
NCT ID: NCT02158520
Description: Adverse events are reported for each arm group (i.e. Arm A, Arm B, Arm A Eligible for Crossover, and Arm B Eligible for Crossover)
Frequency Threshold: 0
Time Frame: Up to 4 years
Study: NCT02158520
Study Brief: Nab-Paclitaxel and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery
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 (Bevacizumab and Nab-paclitaxel) Patients receive bevacizumab 10mg/kg IV over 30-90 minutes on days 1 and 15 and nab-paclitaxel 150 mg/m\^2 IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may cross-over to Arm B within 2-4 weeks. 10 None 2 12 11 12 View
Arm B (Ipilimumab) Patients receive ipilimumab 3 mg/kg IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may cross-over to Arm A within 2-4 weeks. 8 None 4 12 9 12 View
Arm A Eligible for Crossover Arm A patients who experienced progressive disease and eligible for crossover to Arm B AND evaluated for adverse events. 6 None 2 7 7 7 View
Arm B Eligible for Crossover Arm B patients who experienced progressive disease and eligible for crossover to Arm A AND evaluated for adverse events. 5 None 2 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Neoplasms benign, mal, uncpec - Oth spec SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 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
Hemolytic uremic syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 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
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12 View
Gastroesophageal reflux disease 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
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Infections and infestations - Oth spec SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Papulopustular rash SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12 View
White blood cell decreased 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
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Metabolism, nutrition disord - Oth spec SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12 View
Pain in extremity 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
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Proteinuria 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
Pulmonary hypertension 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
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12 View
Pruritus 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
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12 View