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 @ 1:44 AM
Ignite Modification Date: 2025-12-26 @ 12:01 AM
NCT ID: NCT01585194
Description: From baseline to 60 days after last dose of drug, a median of 13.0 months
Frequency Threshold: 5
Time Frame: From baseline to 60 days after last dose of study drug, a median of 13.0 months
Study: NCT01585194
Study Brief: Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma
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 (Nivolumab, Ipilimumab) INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV 16 None 2 35 32 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10. View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (10. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10. View
Increased ALT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (10. View
Increased AST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (10. View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10. View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (10. View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10. View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (10. View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10. View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (10. View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10. View