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 @ 9:42 PM
Ignite Modification Date: 2025-12-25 @ 7:23 PM
NCT ID: NCT01137032
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01137032
Study Brief: Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pandel Cream 0.1% Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days None None 0 19 7 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
RASH None Skin and subcutaneous tissue disorders None View
PYREXIA None General disorders None View
NASOPHARYNGITIS None Infections and infestations None View
SINUS CONGESTION None Respiratory, thoracic and mediastinal disorders None View
ARTHRITIS None Musculoskeletal and connective tissue disorders None View
HEADACHE None Nervous system disorders None View
APPLICATION SITE IRRITATION None Skin and subcutaneous tissue disorders None View
EAR INFECTION None Infections and infestations None View
ANXIETY None Psychiatric disorders None View
PRURITUS None Skin and subcutaneous tissue disorders None View
EXOSTOSIS None Musculoskeletal and connective tissue disorders None View
ARTHRALGIA None Musculoskeletal and connective tissue disorders None View
DIZZINESS None Nervous system disorders None View
RHINITIS ALLERGIC None Respiratory, thoracic and mediastinal disorders None View
OCCULT BLOOD None Investigations None View