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 @ 4:43 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT00479466
Description: None
Frequency Threshold: 5.0
Time Frame: None
Study: NCT00479466
Study Brief: Dose-Range Finding Study for MK0893 (0893-008)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo None None None 5 57 16 57 View
MK0893 20 mg None None None 0 57 11 57 View
MK0893 40 mg None None None 1 57 22 57 View
MK0893 60 mg None None None 0 58 16 58 View
MK0893 80 mg None None None 2 56 12 56 View
Metformin HCL None None None 0 57 13 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood bilirubin increased None Investigations MedDRA 12.0 View
Cerebral haemorrhage None Nervous system disorders MedDRA 12.0 View
Abortion spontaneous None Pregnancy, puerperium and perinatal conditions MedDRA 12.0 View
Pulmonary tuberculosis None Infections and infestations MedDRA 12.0 View
Angina unstable None Cardiac disorders MedDRA 12.0 View
Inguinal hernia None Gastrointestinal disorders MedDRA 12.0 View
Chest pain None General disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper None Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea None Gastrointestinal disorders MedDRA 12.0 View
Nausea None Gastrointestinal disorders MedDRA 12.0 View
Nasopharyngitis None Infections and infestations MedDRA 12.0 View
Accidental overdose None Injury, poisoning and procedural complications MedDRA 12.0 View
Hyperglycaemia None Metabolism and nutrition disorders MedDRA 12.0 View
Arthralgia None Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Pain in extremity None Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Dizziness None Nervous system disorders MedDRA 12.0 View
Headache None Nervous system disorders MedDRA 12.0 View
Cough None Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Influenza None Infections and infestations MedDRA 12.0 View
Upper respiratory tract infection None Infections and infestations MedDRA 12.0 View