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: 2025-12-25 @ 4:33 AM
Ignite Modification Date: 2025-12-26 @ 3:35 AM
NCT ID: NCT01927718
Description: None
Frequency Threshold: 5
Time Frame: Adverse event collection with 28 day treatment cycle, and up to 30 days after the last dose of the study drugs.
Study: NCT01927718
Study Brief: Thalidomide to Overcome Lenalidomide Resistance After Autologous Hematopoietic Stem Cell Transplantation (HCT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Thalidomide + Lenalidomide Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle. None None 0 10 10 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Elevated Aspartate aminotransferase (AST) SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Elevated creatinine SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Elevated alanine transaminase (ALT) SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Loss of balance SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Low white blood count SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Muscle cramping SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nerve pain SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Peripheral neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View