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 @ 11:21 PM
Ignite Modification Date: 2025-12-25 @ 9:04 PM
NCT ID: NCT00443456
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00443456
Study Brief: Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Amlodipine All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study None None 8 134 50 134 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Sick sinus syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.1 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.1 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Gum neoplasm malignant stage unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Malignant ascites SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View