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: 2025-12-26 @ 11:46 AM
Ignite Modification Date: 2025-12-26 @ 11:46 AM
NCT ID: NCT04048616
Description: Standard definitions
Frequency Threshold: 0
Time Frame: up to 24 weeks
Study: NCT04048616
Study Brief: Impact of Protein and Alkali Supplementation on Skeletal Muscle in Older Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Whey Protein Isolate + KHCO3 1.5 gm/kg/day of whey protein and 81 mmol/day of KHCO3 whey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal potassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal 0 None 3 35 22 35 View
Whey Protein Isolate + Microcrystalline Cellulose 1.5 gm/kg/day of whey protein and identical placebo microcrystalline cellulose capsules whey protein isolate: one 15-25 gm (based on body weight) protein packet three times a day with each meal microcrystalline cellulose: identical placebo capsule 0 None 2 36 14 36 View
Maltodextrin Powder + KHCO3 isocaloric placebo maltodextrin powder and 81 mmol/day of KHCO3 potassium bicarbonate (KHCO3): two 13.5 mmol capsules three times a day with each meal maltodextrin powder: isocaloric placebo powder 0 None 3 35 18 35 View
Maltodextrin Powder + Microcrystalline Cellulose isocaloric placebo maltodextrin powder and identical placebo microcrystalline cellulose capsules microcrystalline cellulose: identical placebo capsule maltodextrin powder: isocaloric placebo powder 1 None 3 35 14 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiovascular event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fall with musculoskeletal complication SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peptic ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pedal edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Myocardial infaction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
coronary heart disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ear infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Benign Positional Vertgo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory infections SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peptic ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fall with injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg cramps SYSTEMATIC_ASSESSMENT General disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Basal cell cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Prostate problems SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
cerebrovascular event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dental infection SYSTEMATIC_ASSESSMENT General disorders None View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT General disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View