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 @ 4:02 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT02903966
Description: SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment. Adverse events are presented treatment wise.
Frequency Threshold: 5
Time Frame: SAEs and non-serious AEs were collected from the start of study treatment (Day 1) up to Day 43 in Part A and from Day 44 till follow up visit (Day 112) in Part B.
Study: NCT02903966
Study Brief: GSK2982772 Study in Subjects With Ulcerative Colitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A: Placebo TID DB Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). 0 None 1 12 7 12 View
Part A: GSK2982772 60 mg TID DB Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase). 0 None 0 24 13 24 View
Part B: GSK2982772 60 mg TID OL Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part B (open label phase). 0 None 2 35 7 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Comminuted fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA22.0 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA22.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA22.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Borrelia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA22.0 View
Nasal ulcer SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA22.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA22.0 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA22.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA22.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA22.0 View