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 @ 12:45 AM
Ignite Modification Date: 2025-12-25 @ 10:58 PM
NCT ID: NCT01848067
Description: None
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT01848067
Study Brief: Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate 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
Treatment (Alisertib, Abiraterone Acetate, Prednisone) Patients receive alisertib PO BID on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Alisertib: Given PO Abiraterone acetate: Given PO Prednisone: Given PO 0 None 4 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Memory Loss NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophil Count Decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
gastroesophogeal reflux disease (GERD) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth Sore NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT General disorders None View
WBC decreased NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tongue Swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neutrophil Count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View