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 @ 6:51 PM
Ignite Modification Date: 2025-12-25 @ 4:24 PM
NCT ID: NCT00621257
Description: For 1 year, while participant was on study medication for the maintenance trial.
Frequency Threshold: 3
Time Frame: 6 weeks while participant was on study medication for treatment trial
Study: NCT00621257
Study Brief: Vitamin D Levels in Children With IBD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment B 2,000 IU/day of vitamin D3 orally for 6 weeks Cholecalciferol: 400 units per drop None None 0 24 8 24 View
Treatment C 50,000 IU of vitamin D2 once a week orally for 6 weeks ergocalciferol: 8000 units/ml None None 0 23 4 23 View
Treatment A 2,000 IU/day of vitamin D2 orally for 6 weeks (control arm) ergocalciferol: 8000 units/ml None None 0 24 5 24 View
Maintenance A 400 IU per day of oral vitamin D2 ergocalciferol 8000 IU/ml None None 0 32 19 32 View
Maintenance B 1,000 IU of oral vitamin D2 per day from May to October and 2,000 IU of oral vitamin D2 per day of oral vitamin D2 per day from November to April ergocalciferol 8000 IU/ml None None 0 31 15 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased thirst SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
itching skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
irregular heart beat SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Loss of appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
sensitive eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash on face and body SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Unusual tiredness, or weakness SYSTEMATIC_ASSESSMENT General disorders None View
Metallic taste SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Calcium deposit in tissues outside of bones SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View