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 @ 7:25 PM
Ignite Modification Date: 2025-12-25 @ 5:05 PM
NCT ID: NCT02631603
Description: The adverse events were collected during the study visits or during the telephone visits.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02631603
Study Brief: Stop Exogenous Allergic Alveolitis (EAA) in Childhood
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Capsules of placebo will be taken for 3 months. Placebo: Administer Placebo as anti-inflammatory 0 None 0 1 1 1 View
Prednisolone Oral prednisolone, anticipated dose: first month 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose. Individual capsules will be prepared using rounded dose. Prednisolone: Administer Prednisolone as anti-inflammatory 0 None 0 3 3 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Respiratory tract infection, candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever, headache, haematome, tiredness, hypertension SYSTEMATIC_ASSESSMENT General disorders None View
Cushing habitus, hair growth, weight gain SYSTEMATIC_ASSESSMENT Endocrine disorders None View