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 @ 12:43 PM
Ignite Modification Date:
2025-12-25 @ 12:13 PM
NCT ID:
NCT03210961
Description:
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
Frequency Threshold:
5
Time Frame:
Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
Study:
NCT03210961
Study Brief:
A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis
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 SAD | During the SAD period (Period 1), the healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg cohort SD cohort in fasted state. SAD period duration was 8 days. (Those placebo participants matching 30, 100, 400, or 1600 SD cohort later continued into MAD period and received the placebo matching 30, 100, 400, or 1200 mg QD cohort, respectively.) | 0 | None | 0 | 13 | 1 | 13 | View |
| Placebo QD MAD (JP Placebo Included) | This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants (they had completed the SAD period) received placebo matching PF-06826647 30, 100, 400, or 1200 mg QD cohort while the Japanese participants (they did not take part in SAD period) received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal. MAD period duration was 28 days. | 0 | None | 0 | 9 | 2 | 9 | View |
| Placebo BID | Edit During the MAD period (Period 2), the healthy participants received placebo matching PF-06826647 200 mg BID cohort for 10 days with standard meal. MAD period duration was 28 days. | 0 | None | 0 | 2 | 0 | 2 | View |
| PF-06826647 3 mg SAD | During the SAD period (Period 1), the healthy participants received PF-06826647 3 mg SD in fasted state. SAD period duration was 8 days. | 0 | None | 0 | 6 | 0 | 6 | View |
| PF-06826647 10 mg SAD | During the SAD period (Period 1), the healthy participants received PF-06826647 10 mg SD in fasted state. SAD period duration was 8 days. | 0 | None | 0 | 6 | 0 | 6 | View |
| PF-06826647 30 mg SAD | During the SAD period (Period 1), the healthy participants received PF-06826647 30 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 30 mg QD in MAD period.) | 0 | None | 0 | 8 | 0 | 8 | View |
| PF-06826647 30 mg QD MAD | During the MAD period (Period 2), the healthy participants who had taken PF-06826647 30 mg SD received PF-06826647 30 mg QD for 10 days with standard meal. MAD period duration was 28 days. | 0 | None | 0 | 6 | 2 | 6 | View |
| PF-06826647 100 mg SAD | During the SAD period (Period 1), the healthy participants received PF-06826647 100 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 100 mg QD in MAD period.) | 0 | None | 0 | 7 | 1 | 7 | View |
| PF-06826647 100 mg QD MAD | During the MAD period (Period 2), the healthy participants who had taken PF-06826647 100 mg SD received PF-06826647 100 mg QD for 10 days with standard meal. MAD period duration was 28 days. | 0 | None | 0 | 6 | 1 | 6 | View |
| PF-06826647 400 mg SAD | During the SAD period (Period 1), the healthy participants received PF-06826647 400 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 400 mg QD in MAD period.) | 0 | None | 0 | 8 | 0 | 8 | View |
| PF-06826647 400 mg QD MAD | During the MAD period (Period 2), the healthy participants who had taken PF-06826647 400 mg SD received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days. | 0 | None | 0 | 6 | 1 | 6 | View |
| PF-06826647 1600 mg SAD | During the SAD period (Period 1), the healthy participants received PF-06826647 1600 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 1200 mg QD in MAD period.) | 0 | None | 0 | 6 | 2 | 6 | View |
| PF-06826647 1200 mg QD MAD | During the MAD period (Period 2), the healthy participants who had taken PF-06826647 1600 mg SD received PF-06826647 1200 mg QD for 10 days with standard meal. MAD period duration was 28 days. | 0 | None | 0 | 5 | 1 | 5 | View |
| PF-06826647 200 mg BID | During the MAD period (Period 2), the healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days. | 0 | None | 0 | 7 | 3 | 7 | View |
| PF-06826647 400 mg QD MAD JP | During the MAD period (Period 2), the Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days. | 0 | None | 0 | 5 | 1 | 5 | View |
| Placebo QD PSO | In the psoriasis (PSO) cohorts, the psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD PSO cohort for 28 days with standard meal. Psoriasis cohort duration was 84 days. | 0 | None | 0 | 14 | 7 | 14 | View |
| PF-06826647 400 mg QD PSO | In this psoriasis cohort, the psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days. | 0 | None | 0 | 15 | 12 | 15 | View |
| PF-06826647 100 mg QD PSO | In this psoriasis cohort, the psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days. | 0 | None | 0 | 11 | 5 | 11 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cerumen impaction | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v21.1 | View |
| Ear discomfort | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v21.1 | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Epigastric discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Faeces hard | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v21.1 | View |
| Face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Peripheral swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Secretion discharge | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v21.1 | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v21.1 | View |
| Periorbital haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Periorbital haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v21.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Blood creatine phosphokinase | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Blood uric acid increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Body temperature | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v21.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Sinus headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v21.1 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v21.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v21.1 | View |