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 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 1:19 PM
NCT ID:
NCT01274559
Description:
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
Frequency Threshold:
5
Time Frame:
up to 12 weeks
Study:
NCT01274559
Study Brief:
Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Extended-release Niacin/Laropiprant | ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant. | None | None | 23 | 572 | 101 | 572 | View |
| Placebo | Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks) | None | None | 16 | 572 | 16 | 572 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Aortic valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 15.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Sudden cardiac death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Epiglottitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Puncture site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Meniscus lesion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Bile duct cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Prostatic adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.1 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Postmenopausal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Accelerated hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Diabetic macroangiopathy | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |