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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:04 AM
NCT ID: NCT00217594
Description: None
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT00217594
Study Brief: A Pilot Study of Alemtuzumab (Campath[R]) in Patients With Myelodysplastic Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alemtuzumab Patients received a 1-mg test dose of alemtuzumab, and the following day, alemtuzumab was administered at 10 mg/dose intravenously for 10 days 0 None 15 31 31 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bacterial pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neutropenic fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non-neutropenic fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Autoimmune thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Clostridium difficile diarrhea SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
URI symptoms SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypotension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Molluscum contagiosum skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Stiffness SYSTEMATIC_ASSESSMENT General disorders None View
Facial flushing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Orchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pilonidal cyst SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mycobacterium chelonae SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hand swelling SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased phosphate SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated AST, ALT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated LDH SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Muscle cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neuropathic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Darkened urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View