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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
NCT ID:
NCT00485758
Description:
7 randomized patients took no study drug dose and were not included in the safety follow-up
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00485758
Study Brief:
Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)
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 | Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study. | None | None | 24 | 340 | 113 | 340 | View |
| Extended Release Niacin/Laropiprant | One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram). No adjustments were made to any lipid modifying regimen established during run-in until Week 12. | None | None | 26 | 449 | 251 | 449 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 11.0 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Aortic valve stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 11.0 | View |
| Abdominal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Diverticulum | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Mechanical ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.0 | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Enterocolitis infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Infected skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Meniscus lesion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.0 | View |
| Cervix carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | View |
| Lipoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | View |
| Metastases to penis | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | View |
| Oesophageal carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | View |
| Renal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | View |
| Subarachnoid haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Calculus urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.0 | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.0 | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 11.0 | View |
| Prostatitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 11.0 | View |
| Aortic stenosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Pelvic venous thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Subclavian artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| International normalised ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 11.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 11.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |