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 @ 2:08 AM
Ignite Modification Date: 2025-12-26 @ 12:35 AM
NCT ID: NCT00313560
Description: None
Frequency Threshold: 0
Time Frame: Adverse Event data was collected for approximately 3 years.
Study: NCT00313560
Study Brief: ChemoRT With Adjuvant Chemo in Pancreatic Cancer (TARCEVA)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Erlotinib and EBRT After Prostatectomy Patients receive oral erlotinib hydrochloride once a day for 3-5 days. Patients then proceed to surgery. erlotinib hydrochloride: Given orally 20 None 16 48 31 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal bleeding NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Altered Mental Status NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Small bowel obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Intractable nausea/vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated ALP NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated AST/elevated ALT NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperbilirubinemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View