Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:25 PM
Ignite Modification Date: 2025-12-25 @ 7:11 PM
NCT ID: NCT01711632
Description: None
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT01711632
Study Brief: BRAF Inhibitor, Vemurafenib, in Patients With Relapsed or Refractory Hairy Cell Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vemurafenib Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days). 7 None 13 36 22 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal disorders, other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin & subcutaneous tissue disorders, other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
INR increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hemoglobin increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View