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 @ 11:45 PM
Ignite Modification Date: 2025-12-25 @ 9:37 PM
NCT ID: NCT01093651
Description: SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
Frequency Threshold: 2
Time Frame: 16 weeks
Study: NCT01093651
Study Brief: Dipeptidyl Peptidase-4 Inhibition and Immune Function in HIV
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DPPIV Inhibition Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status. Sitagliptin : 100 mg sitagliptin daily for 4 months None None 0 10 6 10 View
Placebo Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status. Placebo : Daily placebo for 4 months None None 0 10 7 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoglycemia symptoms NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gastrointestinal symptoms NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory symptoms NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Generalized fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Muscle pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Mood change NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View