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 @ 7:38 PM
Ignite Modification Date: 2025-12-25 @ 5:19 PM
NCT ID: NCT01446003
Description: The safety population consisted of all participants who received at least one dose of the investigational drug.
Frequency Threshold: 0
Time Frame: Up to 70 days
Study: NCT01446003
Study Brief: A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MK-8457 100 mg BID Participants received MK-8457 100 mg BID for 10 days None None 0 31 8 31 View
Placebo Participants received Placebo for MK-8457 for 10 days None None 0 29 9 29 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v 15.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v 15.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 15.0 View
Energy decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA v 15.0 View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA v 15.0 View
Swelling of fingers SYSTEMATIC_ASSESSMENT General disorders MedDRA v 15.0 View
Venipuncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v 15.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 15.0 View
White blood cell count abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v 15.0 View
Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 15.0 View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 15.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 15.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 15.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v 15.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v 15.0 View