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 @ 1:04 PM
Ignite Modification Date: 2025-12-25 @ 12:20 PM
NCT ID: NCT02174861
Description: Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Frequency Threshold: 5
Time Frame: From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).
Study: NCT02174861
Study Brief: A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Erenumab Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study. 0 None 24 609 162 609 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial bridging SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 20.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Post procedural oedema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Medication overuse headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Radicular syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Vestibular migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Alcoholism SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Alcoholic liver disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View