Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT04676867
Description: Adverse events (AE) data were collected and analyzed only for subjects who were enrolled and took at least 1 dose of study medication.
Frequency Threshold: 5
Time Frame: Adverse event (AE) data were collected for approximately 1 month. All subjects were closely monitored for adverse events from informed consent for at least 18 days after the final dose of study treatment (until Day 28 ±2). Subjects who withdrew early from the study had follow-up phone calls to collect safety data until End of Study on Day 28±2.
Study: NCT04676867
Study Brief: Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19
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 Tablets Participants received twelve dalcetrapib placebo tablets orally daily for 10 days. Placebo: Dalcetrapib matching placebo tablets 0 None 2 53 29 53 View
900 mg Dose Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets 0 None 4 55 27 55 View
1800 mg Dose Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets 1 None 4 48 33 48 View
3600 mg Dose Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets 0 None 1 52 46 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Proctitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 or later View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 or later View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 or later View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 or later View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 or later View
Rash maculopapular SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 or later View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 or later View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 or later View
Feces soft SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 or later View
Gastric disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 or later View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 or later View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 or later View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 or later View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 or later View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 or later View