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 @ 6:44 PM
Ignite Modification Date:
2025-12-25 @ 4:15 PM
NCT ID:
NCT04006457
Description:
For all-cause mortality, FAS was used. SAS was defined as all participants who took at least 1 dose of study intervention in the main study or sub-study. Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Frequency Threshold:
5
Time Frame:
Main Study: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40). Vaccine Sub-study: From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)
Study:
NCT04006457
Study Brief:
Long-Term PF-06651600 for the Treatment of Alopecia Areata
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study. | 1 | None | 43 | 603 | 372 | 603 | View |
| Vaccine Sub-study: Tdap Vaccination | Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the Tdap vaccine with or without the meningococcal ACWY vaccine were enrolled in this sub-study. | 0 | None | 0 | 17 | 3 | 17 | View |
| Vaccine Sub-study: Meningococcal ACWY Vaccination | Participants who have received atleast 6 months of treatment with PF-06651600 50mg QD in the study B7981032 were continued to receive the study intervention while participating in this vaccine sub-study. Eligible participants who received the meningococcal ACWY vaccine with or without the Tdap vaccine were enrolled in this sub-study. | 0 | None | 0 | 13 | 1 | 13 | View |
| Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. | 1 | None | 33 | 447 | 309 | 447 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cyst rupture | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v27.0 | View |
| Anaphylactic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v27.0 | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v27.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| COVID-19 pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Latent tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Pelvic abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Peritonsillar abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Staphylococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Vulval abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Joint dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Ligament rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Meniscus injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Subdural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Hypovolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Foot deformity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Systemic lupus erythematosus | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Basal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Borderline mucinous tumour of ovary | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Malignant melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Papillary thyroid cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Salivary gland adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Solitary fibrous tumour | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Testis cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Bell's palsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v27.0 | View |
| Abortion threatened | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v27.0 | View |
| Bipolar I disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Bipolar disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Delirium | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Major depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |
| Calculus urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |
| Cervical dysplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v27.0 | View |
| Cervical polyp | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v27.0 | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Miscarriage of partner | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA v27.0 | View |
| Aortic aneurysm | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v27.0 | View |
| Varicose vein | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v27.0 | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Cardio-respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Blindness | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v27.0 | View |
| Retinal artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v27.0 | View |
| Abdominal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Impaired gastric emptying | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| SARS-CoV-2 test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v27.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Rhabdomyolysis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |