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 @ 7:30 PM
Ignite Modification Date: 2025-12-25 @ 5:11 PM
NCT ID: NCT02541903
Description: None
Frequency Threshold: 5
Time Frame: Adverse were collected every month during the study period and post-treatment (within 30 days)
Study: NCT02541903
Study Brief: Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gilotrif Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks). Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur. 4 None 4 8 4 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.03 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.03 View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.03 View
Deep Venous Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.03 View
Pain in scrotal region SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.03 View
Anemia SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.03 View
Decreased platelet count SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.03 View