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 @ 6:48 PM
Ignite Modification Date: 2025-12-25 @ 4:19 PM
NCT ID: NCT02927457
Description: Safety Population comprised of all participants who received at least one dose of a study treatment. Data was not collected for Group A as no participants were dosed.
Frequency Threshold: 0
Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 56
Study: NCT02927457
Study Brief: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of GSK2646264 in Cutaneous Lupus Erythematosus Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group B-Participants With Natural Lesions Participants with natural lesions were topically administered white to off-white aqueous cream of GSK2646264 (1% w/w) and placebo. The treatments were administered at the same time on different skin sites once daily for 28 days. 0 None 1 11 8 11 View
Group A-Participants With Photoprovocation Lesions Participants who developed lesions following 3 consecutive days of photoprovocation were planned to be administered topical white to off-white GSK2646264 (1 percent \[%\] weight by weight \[w/w\]) to 1 lesion and placebo to 1 lesion (at the same time), once daily for 28 consecutive days. Either 1% w/w GSK2646264 or placebo was planned also to be administered to an area of uninvolved skin for 28 days. 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA21.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA21.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA21.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA21.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA21.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA21.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA21.0 View
Postoperative wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA21.0 View
Panniculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA21.0 View