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 @ 2:46 AM
Ignite Modification Date: 2025-12-26 @ 1:27 AM
NCT ID: NCT02471833
Description: Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
Frequency Threshold: 0
Time Frame: Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Study: NCT02471833
Study Brief: Health Evaluation in African Americans Using RAS Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Telmisartan 40mg African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. 0 None 0 18 13 18 View
Placebo African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. 0 None 0 24 15 24 View
Telmisartan 20mg African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months. 0 None 0 19 13 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Excessive swelling SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Postural hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Persistent cough SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angioedema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Syncope SYSTEMATIC_ASSESSMENT General disorders None View
Vertigo SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal kidney function SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Unusual muscle aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Night sweats NON_SYSTEMATIC_ASSESSMENT General disorders None View
Out of range labs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cold symptoms NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Increased body temperature NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acid reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Trouble falling asleep NON_SYSTEMATIC_ASSESSMENT General disorders None View
Indigestion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Difficulty swallowing NON_SYSTEMATIC_ASSESSMENT General disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Heart palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Low energy NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT General disorders None View