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: 2025-12-25 @ 2:03 AM
Ignite Modification Date: 2025-12-26 @ 12:28 AM
NCT ID: NCT01096160
Description: None
Frequency Threshold: 0
Time Frame: 11 days
Study: NCT01096160
Study Brief: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Panel A: Placebo BID Matching placebo capsules, administered orally BID for 10 days 0 None 0 2 0 2 View
Panel B: MK-8266 BID, 1.8 mg MK-8266 1.8 mg (1 mg AM + 0.8 mg PM), administered orally for 10 days 0 None 0 6 5 6 View
Panel B: Placebo BID Matching placebo capsules, administered orally BID for 10 days 0 None 0 2 1 2 View
Panel C: MK-8266 TID, 1.8 mg MK-8266 0.6 mg TID as oral capsules (1.8 mg) for 10 days 0 None 0 6 3 6 View
Panel C: Placebo TID Matching placebo capsules, administered orally TID for 10 days 0 None 0 2 1 2 View
Panel D: MK-8266 TID, 2.4 mg MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days 0 None 0 6 4 6 View
Panel E: MK-8266 TID, 2.4 mg MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days 0 None 0 6 5 6 View
Panel E: Placebo TID Matching placebo capsules, administered orally TID for 10 days 0 None 0 2 2 2 View
Panel A: MK-8266 BID, 1 mg MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days 0 None 0 6 5 6 View
Panel D: Placebo TID Matching placebo capsules, administered orally TID for 10 days 0 None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Abnormal sensation in eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Sluggishness SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View