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 @ 8:01 PM
Ignite Modification Date: 2025-12-25 @ 5:34 PM
NCT ID: NCT03260504
Description: None
Frequency Threshold: 2.5
Time Frame: Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
Study: NCT03260504
Study Brief: Aldesleukin and Pembrolizumab in Treating Patients With Advanced or Metastatic Kidney 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
Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2) Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64. Patients also receive aldesleukin subcutaneously (SC) at 250,000 U/kg/dose, daily, 5 days/wk, week 1; 125,000 U/kg/dose, daily, 5 days/wk, weeks 2-6. 0 None 0 3 3 3 View
Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2) Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64. Patients also receive aldesleukin intravenously (IV) at 72,000 U/kg IV q 8 hrs x 14 doses days 2-6 (cycle 1); and days 23-27 (cycle 2) of a 12-week course. 1 None 1 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE Version 5.0 View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE Version 5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Generalized edema NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 5.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 5.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE Version 5.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 5.0 View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 5.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE Version 5.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE Version 5.0 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 5.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 5.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE Version 5.0 View