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: 2025-12-25 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:56 AM
NCT ID: NCT01422434
Description: Three Serious Adverse Events occoured in subjects not randomized to study treatment: Adverse event term: Laceration, Radius fracture, Ulna fracture, Number of participants at risk in the 'dovonex ointment arm' is not conistent with number in the participant flow module as the AE analysis was done on safety set, not on randomised set.
Frequency Threshold: 5
Time Frame: None
Study: NCT01422434
Study Brief: LEO 90105 Ointment in Japanese Subjects With Psoriasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dovonex® Ointment Applied twice daily for 4 weeks. Dovonex® = calcipotriol : Applied twice daily for 4 weeks. None None 1 226 27 226 View
LEO 90105 Ointment LEO 90105 ointment applied once daily for 4 weeks. LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks. None None 2 226 20 226 View
Rinderon® - DP Ointment Applied once daily for 4 weeks Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks. None None 1 223 16 223 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Calculus urinary NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Acute coronary syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View