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 @ 2:33 AM
Ignite Modification Date: 2025-12-26 @ 1:09 AM
NCT ID: NCT00885534
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00885534
Study Brief: Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cisplatin, Vinblastine, Temozolomide Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following: Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1. None None 2 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC 4.0 View
Dehydration SYSTEMATIC_ASSESSMENT General disorders CTC-4.0 View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTC-4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Urogenital disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTC-3.0 View
ALT, SGPT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Fever (in the absence of neutropenia) SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Glucose, high (hyperglycemia) SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Potassium, high (hyperkalemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-3.0 View
Bilirubin (hyperbilirubinemia) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
INR increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Leukocytes (total WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-3.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-3.0 View
Fatigue (asthenia, lethargy, malaise) SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View