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 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 12:52 PM
NCT ID:
NCT01856595
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01856595
Study Brief:
PF-06291874 Multiple Ascending Dose Study In Type 2 Diabetes Mellitus Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part A: PF-06291874 50 mg | Participants received PF-06291874 50 mg orally once daily for 14 days | None | None | 0 | 12 | 6 | 12 | View |
| Part A: PF-06291874 100 mg | Participants received PF-06291874 100 mg orally once daily for 28 days | None | None | 0 | 14 | 5 | 14 | View |
| Part A: PF-06291874 5 mg | Participants received PF-06291874 5 milligram (mg) orally once daily for 14 days | None | None | 0 | 12 | 7 | 12 | View |
| Part A: PF-06291874 15 mg | Participants received PF-06291874 15 mg orally once daily for 14 days | None | None | 0 | 12 | 4 | 12 | View |
| Part A: PF-06291874 150 mg | Participants received PF-06291874 150 mg orally once daily for 14 days | None | None | 0 | 12 | 3 | 12 | View |
| Part B: Placebo | Participants received placebo matched to PF-06291874 orally once daily for 14 or 28 days | None | None | 0 | 13 | 8 | 13 | View |
| Part B: PF-06291874 15 mg | Participants received PF-06291874 15 mg orally once daily for 14 days | None | None | 0 | 10 | 5 | 10 | View |
| Part B: PF-06291874 30 mg | Participants received PF-06291874 30 mg orally once daily for 28 days | None | None | 0 | 14 | 5 | 14 | View |
| Total | None | None | None | 0 | 117 | 53 | 117 | View |
| Part A: Placebo | Participants received placebo matched to PF-06291874 orally once daily for 14 or 28 days | None | None | 0 | 18 | 10 | 18 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Normochromic normocytic anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Supraventricular extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Chromatopsia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Application site bruise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Vessel puncture site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Abnormal dreams | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Libido decreased | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Urinary hesitation | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Pruritus generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Skin irritation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |