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:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT04753606
Description:
Safety Population included all participants who received at least 1 dose of any study drug.
Frequency Threshold:
0
Time Frame:
From first dose of study drug through week 12
Study:
NCT04753606
Study Brief:
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
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 | once-daily placebo Obicetrapib: tablets | 0 | None | 2 | 40 | 17 | 40 | View |
| Obicetrapib 5 mg | once-daily obicetrapib Obicetrapib: tablets | 0 | None | 0 | 40 | 15 | 40 | View |
| Obicetrapib 10 mg | once-daily obicetrapib Obicetrapib: tablets | 0 | None | 0 | 40 | 8 | 40 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pelvic Pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Perineal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.1 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.1 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.1 | View |
| Irritable bowel syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Colitis microscopic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Bone contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Platelet count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Polycythaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.1 | View |
| Epicondylitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.1 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Temporomandibular joint syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.1 | View |
| Arthropod sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.1 | View |
| Vaccination complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.1 | View |
| Cardiomegaly | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.1 | View |