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 @ 10:41 PM
Ignite Modification Date: 2025-12-25 @ 8:12 PM
NCT ID: NCT01244035
Description: None
Frequency Threshold: 0
Time Frame: MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
Study: NCT01244035
Study Brief: Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008)
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-8266 1.3 mg BID MK-8266 administered as 1.0 mg in the morning + 0.3 mg 8 hours later on Days 1, 2, and 3 0 None 0 25 9 25 View
MK-8266 0.9 mg FDD MK-8266 administered as 0.1 mg every 2 hours on Days 1, 2, and 3 0 None 0 26 16 26 View
MK-8266 1 mg QD MK-8266 administered a single 1 mg dose on Day 4 0 None 0 26 8 26 View
Placebo Placebo matching MK-8266 administered on Days 1, 2, 3 and 4 0 None 0 27 9 27 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Accelerated idioventricular rhythm SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Vessel puncture site inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Open wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Blood pressure diastolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood pressure systolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Sensation of heaviness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hemicephalalgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View