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 @ 1:37 PM
Ignite Modification Date: 2025-12-25 @ 12:36 PM
NCT ID: NCT01656395
Description: The safety population consisted of all randomized participants who received ≥1 dose of study drug.
Frequency Threshold: 5
Time Frame: Up to 14 weeks (Up to 2 weeks after last dose of study drug)
Study: NCT01656395
Study Brief: A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012)
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-1029 10 mg Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks 0 None 0 58 15 58 View
MK-1029 30 mg Participants receive MK-1029 30 mg tablets QD for 12 weeks 0 None 2 126 24 126 View
MK-1029 60 mg Participants receive MK-1029 two 30 mg tablets QD for 12 weeks 0 None 2 135 27 135 View
Montelukast 10 mg Participants receive Montelukast 10 mg tablets QD for 12 weeks 0 None 0 60 19 60 View
Placebo Participants receive Placebo tablets QD for 12 weeks 0 None 1 126 42 126 View
MK-1029 150 mg Participants receive MK-1029 150 mg tablets QD for 12 weeks 0 None 1 52 19 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MeDRA 17.0 View
Kaposi's varicelliform eruption SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 17.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 17.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MeDRA 17.0 View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MeDRA 17.0 View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 17.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 17.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 17.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 17.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 17.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 17.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 17.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 17.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 17.0 View