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 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
NCT ID:
NCT00941603
Description:
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
Frequency Threshold:
5
Time Frame:
up to approximately 96 days (including 30 days following last dose for serious adverse events)
Study:
NCT00941603
Study Brief:
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SCH 900271 15 mg | Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks | None | None | 4 | 103 | 41 | 103 | View |
| SCH 900271 5 mg | Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks | None | None | 3 | 104 | 19 | 104 | View |
| SCH 900271 2.5 mg | Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks | None | None | 0 | 104 | 8 | 104 | View |
| Placebo | Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks | None | None | 0 | 97 | 5 | 97 | View |
| SCH 900271 10 mg | Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks | None | None | 1 | 105 | 41 | 105 | View |
| SCH 900271 1 mg | Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks | None | None | 0 | 105 | 14 | 105 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Tenderness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| Hepatitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Facial bones fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |