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: 2025-12-25 @ 12:00 AM
Ignite Modification Date: 2025-12-25 @ 9:58 PM
NCT ID: NCT00791258
Description: AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Frequency Threshold: 2.0
Time Frame: Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose.
Study: NCT00791258
Study Brief: A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks None None 13 999 241 999 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.0) View
depession SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (12.0) View
oesophageal rupture SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
Non small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (12.0) View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
vaginal haemhorrage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (12.0) View
road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (12.0) View
muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (12.0) View
protate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (12.0) View
asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View
oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA (12.0) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.0) View