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 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
NCT ID:
NCT05093205
Description:
None
Frequency Threshold:
5
Time Frame:
From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
Study:
NCT05093205
Study Brief:
STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Midazolam 5 mg (Part A Period 2) | Participants received single dose of midazolam 5 mg orally on Day 1 of Period 2 in Part A. | 0 | None | 0 | 18 | 3 | 18 | View |
| Atorvastatin 20 mg (Part A Period 1) | Participants received single dose of atorvastatin 20 mg orally on Day 1 of Period 1 in Part A. | 0 | None | 0 | 18 | 2 | 18 | View |
| PF-06882961 Titration up to 120 mg BID (Part A Period 3) | Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 3 in Part A. | 0 | None | 0 | 17 | 13 | 17 | View |
| PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4) | Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4 in Part A. | 0 | None | 0 | 13 | 5 | 13 | View |
| PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5) | Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A. | 0 | None | 0 | 13 | 4 | 13 | View |
| PF-06882961 Titration up to 200 mg BID (Part A Period 6) | Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A. | 0 | None | 0 | 13 | 12 | 13 | View |
| PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7) | Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A. | 0 | None | 0 | 5 | 5 | 5 | View |
| PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8) | Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A. | 0 | None | 0 | 6 | 2 | 6 | View |
| 0.15 mg LE & 0.03 mg EE (Part B Period 1) | Participants received single dose of oral contraceptive on Day 1 of Period 1 in Part B. | 0 | None | 0 | 17 | 5 | 17 | View |
| PF-06882961 Titration up to 120 mg BID (Part B Period 2) | Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 2 in Part B. | 0 | None | 0 | 16 | 15 | 16 | View |
| PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3) | Participants received PF-06882961 120 mg BID + OC SD on Day 1 and PF-06882961 120 mg BID on Days 2-5 of Period 3 in Part B. | 0 | None | 0 | 14 | 7 | 14 | View |
| PF-06882961 Titration up to 200 mg BID (Part B Period 4) | Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 4 in Part B. | 0 | None | 0 | 12 | 12 | 12 | View |
| PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5) | Participants received PF-06882961 200 mg BID + oral contraceptive SD on Day 1 and PF-06882961 200 mg BID on Days 2-5 of Period 5 in Part B. | 0 | None | 0 | 9 | 7 | 9 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Glomerular filtration rate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Feeling jittery | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v25.1 | View |
| Sunburn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Blood calcitonin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Blood thyroid stimulating hormone increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| SARS-CoV-2 test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Initial insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Middle insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v25.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Retching | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Joint stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Limb discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Ageusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Disturbance in attention | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Electric shock sensation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Abnormal dreams | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Self esteem decreased | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |