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 @ 10:55 PM
Ignite Modification Date: 2025-12-25 @ 8:23 PM
NCT ID: NCT00465569
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00465569
Study Brief: A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Treatment Adverse event information is based on percentages of doses. There were 2437 total doses in the active treatment arm with a median of 177 and a range of 155-242 per participant. There was a total of 13 participants in the active treatment arm who were analyzed for the Adverse Events data reported below. 0 None 0 2437 1107 2437 View
Placebo Adverse event information is based on percentages of doses. There were 1193 total doses in the placebo arm with a median of 171 and a range of 152-199 per participant. There was a total of 7 participants in the placebo arm who were analyzed for the Adverse Events data reported below. 0 None 0 1193 134 1193 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Local symptoms NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastrointestinal None Gastrointestinal disorders None View
Lower respiratory None Respiratory, thoracic and mediastinal disorders None View
Skin None Skin and subcutaneous tissue disorders None View
Multiple systems None General disorders None View
Eczema flare None Skin and subcutaneous tissue disorders None View