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 @ 11:48 PM
Ignite Modification Date: 2025-12-25 @ 9:42 PM
NCT ID: NCT02797951
Description: All participants who received at least one dose of study drug.
Frequency Threshold: 5
Time Frame: Baseline through End of Study (Up to 4 Years)
Study: NCT02797951
Study Brief: A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Galcanezumab 300 mg SC Participants received 300 mg Galcanezumab administered SC up to once a month. 1 None 17 164 62 164 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
Sarcoidosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Cartilage injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
Exposure to household chemicals SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
Bladder neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.1 View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.1 View
Cluster headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.1 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.1 View
Arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View