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 @ 3:45 AM
Ignite Modification Date: 2025-12-26 @ 2:31 AM
NCT ID: NCT01785602
Description: None
Frequency Threshold: 5
Time Frame: Serious adverse events were collected from day 1 until 4 weeks after end of study (week 20)
Study: NCT01785602
Study Brief: Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe 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
QAW039 Participants received QAW039 450 mg daily by mouth. None None 1 76 44 76 View
Placebo Participants received matching placebo to QAW039. None None 4 27 16 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View