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 @ 6:31 PM
Ignite Modification Date: 2025-12-25 @ 4:01 PM
NCT ID: NCT00372957
Description: Safety Population was used for the analysis.
Frequency Threshold: 0
Time Frame: AEs and SAEs were collected up to post-study screen (Follow-up [7 days after the last dose of study medication]).
Study: NCT00372957
Study Brief: Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. 0 None 0 10 1 10 View
GW823093C 15 mg Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. 0 None 0 10 0 10 View
GW823093C 30 mg Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. 0 None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View