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 @ 2:21 AM
Ignite Modification Date: 2025-12-26 @ 12:53 AM
NCT ID: NCT05932134
Description: adverse event defined as related to the intervention. If the mortality was not happened during intervention period or directly related to the intervention, it's not defined as adverse events of this study.
Frequency Threshold: 0
Time Frame: from enrollment through the end of the admission, up to 3 months
Study: NCT05932134
Study Brief: High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care Usual care as RCC protocol in Chang Gung Memorial hospital 3 None 0 10 0 10 View
UC + High Protein Diet (HP) The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day. 5 None 0 30 0 30 View
UC + HP + Core Muscle Rehabilitation Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks. 5 None 0 30 0 30 View
UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES) NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \[range 50-65 mA\]. 4 None 0 30 0 30 View
Serious Events(If Any):
Other Events(If Any):