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 @ 10:10 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT02403635
Description: None
Frequency Threshold: 0
Time Frame: Up to 32 days after the last dose
Study: NCT02403635
Study Brief: Drug-Drug Interaction Study: ASP2151 and Midazolam
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Total None 0 None 0 18 18 18 View
Midazolam 7.5 mg midazolam 0 None 0 18 17 18 View
ASP2151 After Midazolam 400 mg ASP2151 after 7.5 mg midazolam 0 None 0 18 4 18 View
Midazolam With ASP2151 7.5 mg midazolam with 400 mg ASP2151 0 None 0 18 17 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/18.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/18.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/18.0 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/18.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/18.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/18.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/18.0 View
Catheter site inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA/18.0 View
Energy increased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA/18.0 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA/18.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/18.0 View
Lip haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/18.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA/18.0 View
Rhabdomyolysis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA/18.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA/18.0 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA/18.0 View
Ear discomfort NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA/18.0 View
Conjunctivitis allergic NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA/18.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA/18.0 View