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 @ 2:06 PM
Ignite Modification Date: 2025-12-25 @ 12:49 PM
NCT ID: NCT04518995
Description: All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety population included all participants who received study drug during the treatment period.
Frequency Threshold: 5
Time Frame: All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
Study: NCT04518995
Study Brief: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
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 received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. 0 None 4 140 31 140 View
CTP-543 8 mg BID Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. 0 None 4 350 117 350 View
CTP-543 12 mg BID Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. 0 None 1 215 75 215 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 23.1 View
Adjustment disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Blood creatine phosphokinase (increased) SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View