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 @ 12:19 PM
Ignite Modification Date: 2025-12-25 @ 12:02 PM
NCT ID: NCT00902161
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00902161
Study Brief: A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MK0893 + Propanolol Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21). None None 0 22 10 22 View
Placebo + Propanolol Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21). None None 0 22 4 22 View
Propanolol Alone Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures). None None 0 22 9 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Iron Deficiency Anaemia None Blood and lymphatic system disorders MedDRA 14.0 View
Arrhythmia Supraventricular None Cardiac disorders MedDRA 14.0 View
Vision Blurred None Eye disorders MedDRA 14.0 View
Abdominal Pain None Gastrointestinal disorders MedDRA 14.0 View
Diarrhoea None Gastrointestinal disorders MedDRA 14.0 View
Nausea None Gastrointestinal disorders MedDRA 14.0 View
Chest Discomfort None General disorders MedDRA 14.0 View
Chest Pain None General disorders MedDRA 14.0 View
Fatigue None General disorders MedDRA 14.0 View
Feeling Hot None General disorders MedDRA 14.0 View
Gastroenteritis Viral None Infections and infestations MedDRA 14.0 View
Wrist Fracture None Injury, poisoning and procedural complications MedDRA 14.0 View
Haematocrit Decreased None Investigations MedDRA 14.0 View
Haemoglobin Decreased None Investigations MedDRA 14.0 View
Arthralgia None Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Joint Effusion None Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Dizziness None Nervous system disorders MedDRA 14.0 View
Dizziness Postural None Nervous system disorders MedDRA 14.0 View
Headache None Nervous system disorders MedDRA 14.0 View
Somnolence None Nervous system disorders MedDRA 14.0 View
Insomnia None Psychiatric disorders MedDRA 14.0 View
Hyperhidrosis None Skin and subcutaneous tissue disorders MedDRA 14.0 View