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 @ 4:18 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT04684420
Description: The Safety Analysis Set included all participants who administered at least one dose of study interventions.
Frequency Threshold: 0
Time Frame: From informed consent (Day-28 to Day-2) up to 3 weeks, a maximum of 49 days.
Study: NCT04684420
Study Brief: GXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reference GXR (Fasting) Participants received a single oral dose of 500 mg of reference GXR tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. 0 None 0 47 7 47 View
Test GXR RM (Fasting) Participants received a single oral dose of 500 mg of test GXR RM tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fasting conditions. There was a washout period of 7 days between two treatment period. 0 None 0 48 7 48 View
Reference GXR (Fed) Participants received a single oral dose of 500 mg of reference GXR tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. 0 None 0 32 3 32 View
Test GXR RM (Fed) Participants received a single oral dose of 500 mg of test GXR RM tablet either on Day 1 in treatment period 1 or on Day 8 in treatment period 2 under fed conditions. There was a washout period of 7 days between two treatment period. 0 None 0 31 2 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Human chorionic gonadotropin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
White blood cells urine positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.0 View
Electrocardiogram QT prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
White blood cell count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
Blood lactic acid increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
Electrocardiogram PR prolongation NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View
Glomerular filtration rate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View