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 @ 5:39 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT01130168
Description: Adverse event data were unavailable for 4 participants in the Placebo treatment group and for 1 participant in the Amlodipine treatment group due to discontinuations during Period 1.
Frequency Threshold: 5.0
Time Frame: None
Study: NCT01130168
Study Brief: The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (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
Placebo Placebo was administered as a single once daily dose during 4 weeks of treatment. None None 0 34 7 34 View
ISMN ER Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks. None None 0 38 18 38 View
Amlodipine Amlodipine was administered as a 10 mg single daily dose over 4 weeks. None None 0 37 9 37 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea None Gastrointestinal disorders MedDRA (14.0) View
Vomiting None Gastrointestinal disorders MedDRA (14.0) View
Oedema Peripheral None General disorders MedDRA (14.0) View
Headache None Nervous system disorders MedDRA (14.0) View
Tension Headache None Nervous system disorders MedDRA (14.0) View