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 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
NCT ID:
NCT02691702
Description:
None
Frequency Threshold:
5
Time Frame:
Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14).
Study:
NCT02691702
Study Brief:
Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| PF-05251749 50 mg AM (Part A) | Participants received PF-05251749 50 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14. | 0 | None | 0 | 8 | 3 | 8 | View |
| PF-05251749 400 mg AM (Part A) | Participants received PF-05251749 400 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14. | 0 | None | 0 | 8 | 7 | 8 | View |
| PF-05251749 50 mg PM (Part B) | Participants received PF-05251749 50 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14. | 0 | None | 1 | 8 | 4 | 8 | View |
| PF-05251749 500 mg PM (Part B) | Participants received PF-05251749 500 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14. | 0 | None | 0 | 8 | 8 | 8 | View |
| Placebo (Part A) | Participants received placebo suspensions matched to PF-05251749 at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14. | 0 | None | 0 | 10 | 4 | 10 | View |
| Melatonin 0.5 mg PM (Part A) | Participants received placebo suspensions matched to PF-05251749 at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received melatonin 0.5 mg at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14. | 0 | None | 0 | 11 | 3 | 11 | View |
| PF-05251749 100 mg AM (Part A) | Participants received PF-05251749 100 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14. | 0 | None | 0 | 8 | 1 | 8 | View |
| PF-05251749 200 mg AM (Part A) | Participants received PF-05251749 200 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14. | 0 | None | 0 | 8 | 5 | 8 | View |
| PF-05251749 750 mg AM (Part A) | Participants received PF-05251749 750 mg orally at 08:00 AM after an overnight fast on Days 1, 7, 14 (other doses were administered outside a window of ±2 hours of giving food), and also received placebo capsules matched to melatonin at 06:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14. | 0 | None | 0 | 8 | 7 | 8 | View |
| Placebo (Part B) | Participants received placebo suspensions matched to PF-05251749 at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14. | 0 | None | 0 | 12 | 3 | 12 | View |
| PF-05251749 200 mg PM (Part B) | Participants received PF-05251749 200 mg orally at 6:00 PM outside a window of ±2 hours of giving food. Dosing continued every day until the final dose was administered on Day 14. | 0 | None | 0 | 8 | 2 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Frequent bowel movements | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Electrocardiogram T wave inversion | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Hepatic enzyme abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |