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 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
NCT ID:
NCT02969018
Description:
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Frequency Threshold:
5
Time Frame:
From first dose of study treatment up to 20 weeks
Study:
NCT02969018
Study Brief:
Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe 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 |
|---|---|---|---|---|---|---|---|---|
| PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD | Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets). | 1 | None | 2 | 25 | 11 | 25 | View |
| PF-06700841 60 mg QD Followed by 10 mg QD | Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). | 0 | None | 1 | 29 | 14 | 29 | View |
| PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW) | Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). | 0 | None | 1 | 26 | 13 | 26 | View |
| PF-06700841 60 mg QD Followed by Placebo | Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets). | 0 | None | 1 | 25 | 13 | 25 | View |
| PF-06700841 30 mg QD | Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets. | 0 | None | 0 | 29 | 13 | 29 | View |
| PF-06700841 30 mg QD Followed by 10 mg QD | Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets). | 0 | None | 0 | 25 | 12 | 25 | View |
| PF-06700841 30 mg QD Followed by 100 mg QW | Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets). | 0 | None | 0 | 30 | 16 | 30 | View |
| Placebo | Participants received 12 weeks of blinded matching placebo QD tablets. | 0 | None | 0 | 23 | 9 | 23 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gun shot wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v20.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v20.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v20.1 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Cheilitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v20.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v20.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Ligament sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v20.1 | View |