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 @ 5:20 PM
Ignite Modification Date: 2025-12-25 @ 2:56 PM
NCT ID: NCT03118050
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were monitored from baseline through 1 week following completion of the intervention period.
Study: NCT03118050
Study Brief: Identifying Therapeutic Targets of Accelerated Sarcopenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bed Rest in Type 2 Diabetes (T2DM), High-dose Amino Acids (HAA) Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064 0 None 0 5 0 5 View
Bed Rest in Healthy Subjects, Physical Therapy (PT)Subjects, PT Healthy subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064 0 None 0 6 0 6 View
Resistance Training in Type 2 Diabetes (T2DM) Type 2 diabetes subjects will undergo 3 months of resistance exercise training. Muscle size, strength and response to a low dose amino acids will be measured before and after training. Results of this arm will be compared to those previously obtained in healthy older subjects who participated in NCT02999802 (same training protocol) after 1:1 matching for age and sex. Resistance exercise training: Supervised resistance exercise training, 3 times a week for 3 months 0 None 0 15 0 15 View
Bed Rest in Healthy Subjects, Low-dose Amino Acids (LAA) Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064 0 None 0 7 0 7 View
Bed Rest in Healthy Subjects, High-dose Amino Acids (HAA) Healthy subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a high dose amino acids (HAA) will be measured before and after bed rest. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064 1 None 0 5 0 5 View
Bed Rest in Type 2 Diabetes (T2DM), Low-dose Amino Acids (LAA) Type 2 diabetes (T2DM) subjects will undergo short term bed rest with standard of care physical therapy. Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days. UTMB IRB 17-0064 0 None 0 6 0 6 View
Bed Rest in Type 2 Diabetes (T2DM), Physical Therapy (PT) Type 2 diabetes (T2DM) subjects will undergo short term bed rest with intensive physical therapy (PT). Muscle size, strength and response to a low dose amino acids (LAA) will be measured before and after bed rest. Bed rest: Bed rest for 5 days, followed by standard rehabilitation for 2 days Intensive physical therapy: Intensive weight bearing PT, daily, during bed rest. UTMB IRB 17-0064 0 None 0 6 1 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Home medication error SYSTEMATIC_ASSESSMENT Vascular disorders None View