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 @ 11:51 PM
Ignite Modification Date: 2025-12-25 @ 9:45 PM
NCT ID: NCT03167151
Description: The investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study.
Frequency Threshold: 0
Time Frame: Adverse event monitoring starts on the day of the TURBT procedure (Day -14) until 90 days post treatment, or 30 days following administration of the last dose of study medication if the subject initiates a new anticancer therapy.
Study: NCT03167151
Study Brief: Pembrolizumab in Intermediate Risk Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Safety run-in Phase Cohort 3 Cohort 3 in the safety run-in phase. Day 1 starting dose 200mg intravesical pembrolizumab 0 None 0 2 2 2 View
Safety run-in Phase Cohort 1 Cohort 1 in the safety run-in phase. Day 1 starting dose 50mg intravesical pembrolizumab 0 None 1 2 2 2 View
Safety run-in Phase Cohort 2 Cohort 2 in the safety run-in phase. Day 1 starting dose 100mg intravesical pembrolizumab 0 None 0 2 1 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hot flushes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rigors SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Urgency-Frequency Syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View