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 @ 2:48 AM
Ignite Modification Date: 2025-12-26 @ 1:29 AM
NCT ID: NCT02776033
Description: SAEs and non-SAEs were reported for the Safety Population.
Frequency Threshold: 5
Time Frame: Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment until follow-up (up to Day 116)
Study: NCT02776033
Study Brief: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Repeat Doses of GSK2982772 in 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
GSK2982772 60 mg BID Eligible participants received GSK2982772, 60 mg orally BID for 12 weeks in Cohort 1 of the study. 1 None 1 23 21 23 View
GSK2982772 60 mg TID Eligible participants received GSK2982772, 60 mg orally TID for 12 weeks in Cohort 2 of the study. 0 None 1 24 16 24 View
Placebo Eligible participants received placebo orally BID, for 12 weeks in Cohort 1 and orally TID for 12 weeks in Cohort 2 of the study. 0 None 0 18 8 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA20.1 View
Procedural hypertension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA20.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA20.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA20.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA20.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA20.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA20.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA20.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA20.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA20.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA20.1 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA20.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA20.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA20.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA20.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA20.1 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA20.1 View