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 @ 1:33 PM
Ignite Modification Date: 2025-12-25 @ 12:34 PM
NCT ID: NCT00453895
Description: None
Frequency Threshold: 5
Time Frame: up to 1 year
Study: NCT00453895
Study Brief: Sunitinib in Refractory Adrenocortical 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
Sunitinib Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off. treatment will continue until progressive disease or unacceptable toxicity Sunitinib : None None 10 39 39 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dizziness/drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
myocard infarcton SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hypogylcimia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
liver failure SYSTEMATIC_ASSESSMENT General disorders None View
adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Polyneuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
rash or discolored nails NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
mucositis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia, Thrombopenia, Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hemorrhage NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View