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 @ 3:04 AM
Ignite Modification Date: 2025-12-26 @ 1:43 AM
NCT ID: NCT04437433
Description: None
Frequency Threshold: 5
Time Frame: All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Study: NCT04437433
Study Brief: A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Atogepant 60 mg Chronic Migraine Participants with chronic migraine (CM) who completed lead-in Study 3101-303-002 (NCT03855137) received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks. 0 None 7 155 108 155 View
Atogepant 60 mg Episodic Migraine Participants with episodic migraine (EM) who were newly recruited and met all study entry criteria received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks. 0 None 0 31 24 31 View
Total Participants received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks. 0 None 7 186 132 186 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.0 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
UTERINE LEIOMYOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
LOSS OF CONSCIOUSNESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
MIGRAINE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DRY EYE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
MALAISE SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
CYSTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
GINGIVITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View