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: 2025-12-24 @ 1:28 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT00501995
Description: None
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT00501995
Study Brief: High Dose Cyclophosphamide for Treatment of Scleroderma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IV Cyclophosphamide (50 mg/kg) This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter . IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day) None None 1 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
sexual dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
amenorrhea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
itch SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
myalgias SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
neutropenic fever SYSTEMATIC_ASSESSMENT Immune system disorders None View
nausea/vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
oedema SYSTEMATIC_ASSESSMENT Vascular disorders None View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
septic bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View