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 @ 1:41 AM
Ignite Modification Date: 2025-12-25 @ 11:57 PM
NCT ID: NCT01552694
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01552694
Study Brief: Effectiveness of Sitagliptin for HIV Insulin Resistance and Inflammation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sitagliptin 100 mg sitagliptin/day for 2 months Sitagliptin: Oral, 100 mg/day for 2 months None None 0 18 8 18 View
Placebo Matching placebo daily for 2 months Placebo: oral, matching placebo daily for 2 months None None 0 20 8 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatique, Fever, Chills, Loss of appetite, Weight Loss SYSTEMATIC_ASSESSMENT General disorders None View
Sinus, respiratoy urinary tract infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash, pruritus, easy bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chest pain, shortness of breath, wheezing, cough SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain, nausea, vomiting, constipation, diarrhea, hypoglycemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chnages in urinary frequency, painful urination, blood in urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
muscle ache, arthritis, swelling, weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
headaches, dizziness ,numbness, depression, anxiety, confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View