Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 7:13 PM
Ignite Modification Date: 2025-12-25 @ 4:48 PM
NCT ID: NCT00356603
Description: Safety Population was used for the analysis of safety data. Safety population consisted of patients who received at least one dose of study medication.
Frequency Threshold: 0
Time Frame: All Adverse events and serious adverse events that occurred after administration of the investigational product (including the day of administration) and before last participant last visit were analyzed (approximately 2 months).
Study: NCT00356603
Study Brief: Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Migraine Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh. 0 None 0 33 5 33 View
Cluster Headache Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh. 0 None 0 33 10 33 View
Migraine + Cluster Headache Participants with migraine and cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh. 0 None 0 66 15 66 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Choking sensation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngeal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View