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 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:12 AM
NCT ID: NCT03594227
Description: None
Frequency Threshold: 3
Time Frame: Double blind period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the 30 days after the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until 30 days after the subject's last visit.
Study: NCT03594227
Study Brief: ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ATI-501 400mg BID Dosing ATI-501 400mg BID dosing - oral administration ATI-501 400mg BID dosing: ATI-501 oral low dose 0 None 0 23 5 23 View
ATI-501 600mg BID Dosing ATI-501 600mg BID dosing - oral administration ATI-501 600mg BID dosing: ATI-501 oral low dose 0 None 0 23 2 23 View
ATI-501 800mg BID Dosing ATI-501 800mg BID dosing - oral administration ATI-501 800mg BID dosing: ATI-501 high dose for oral administration 0 None 0 22 3 22 View
Placebo Placebo: BID - oral administration 0 None 0 19 3 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (22.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (22.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (22.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (22.0) View
Feces soft SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (22.0) View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (22.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (22.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (22.0) View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (22.0) View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (22.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (22.0) View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (22.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (22.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (22.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (22.0) View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (22.0) View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (22.0) View
Adnexa uteri pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (22.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (22.0) View