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 @ 11:02 PM
Ignite Modification Date: 2025-12-25 @ 8:31 PM
NCT ID: NCT00717769
Description: Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks.
Study: NCT00717769
Study Brief: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
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 Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days. 0 None 3 120 46 120 View
SUN13834 50 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) tid orally 3 times a day (tid) for 28 days. 0 None 0 120 44 120 View
SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 200 mg (2×100 mg) tid orally 3 times a day (tid) for 28 days. 0 None 0 30 11 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (11.1) View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (11.1) View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (11.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View