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 @ 3:19 AM
NCT ID: NCT02647320
Description: None
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
Study: NCT02647320
Study Brief: 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DS-8500a 25mg One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose 0 None 1 43 7 43 View
DS-8500a 50 mg Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose 0 None 0 44 2 44 View
DS-8500a 75 mg Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose 0 None 1 68 11 68 View
Sitagliptin 100 mg Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose 0 None 1 68 6 68 View
Placebo Three placebo tablets and one placebo capsule in a once-daily oral dose 0 None 0 69 7 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
Normochromic normocytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View