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 @ 10:49 PM
Ignite Modification Date: 2025-12-25 @ 8:18 PM
NCT ID: NCT01614769
Description: None
Frequency Threshold: 5
Time Frame: Up to 14 days after last dose of study drug
Study: NCT01614769
Study Brief: Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received placebo in a treatment period. None None 0 9 3 9 View
Glimepiride 2 mg Participants received 2 mg Glimepiride in a treatment period. None None 0 6 2 6 View
Glimepiride 4 mg Participants received 4 mg Glimepiride in a treatment period. None None 0 7 4 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.1 View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 15.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.1 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 15.1 View