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 @ 5:51 PM
Ignite Modification Date:
2025-12-25 @ 3:17 PM
NCT ID:
NCT02974868
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.
Participants were counted only once per treatment per event.
Frequency Threshold:
5
Time Frame:
From first dose of study treatment up to 113 weeks
Study:
NCT02974868
Study Brief:
Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With 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 |
|---|---|---|---|---|---|---|---|---|
| Treatment Period-PF-06700841 | Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period. | 0 | None | 2 | 47 | 28 | 47 | View |
| Single Blind Extension-Active Non-responders on PF-06651600 | Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT \[SALT 30\]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period | 0 | None | 0 | 16 | 8 | 16 | View |
| Single Blind Extension-Placebo Non-responders on PF-06651600 | Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period | 0 | None | 0 | 17 | 12 | 17 | View |
| Single Blind Extension-Active Non-responders on PF-06700841 | Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period | 0 | None | 0 | 5 | 4 | 5 | View |
| Single Blind Extension-Placebo Non-responders on PF-06700841 | Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period | 0 | None | 0 | 12 | 10 | 12 | View |
| SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment | Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period | 0 | None | 0 | 8 | 4 | 8 | View |
| SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment) | Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period | 0 | None | 0 | 9 | 6 | 9 | View |
| SBE-Retreated PF-06700841 Responders in the Withdrawal Segment | Participants initially treated with PF06700841 in the Initial 24- Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841.This arm described AEs for retreated responders within Withdrawal Segment | 0 | None | 0 | 14 | 9 | 14 | View |
| SBE-Retreated PF-06651600 Responders in Retreatment Segment | Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600 | 0 | None | 0 | 14 | 11 | 14 | View |
| SBE-Retreated Responders on PF-06700841 in Retreatment Segment | Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841 | 0 | None | 1 | 15 | 8 | 15 | View |
| Treatment Period-Placebo | Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841 | 0 | None | 0 | 47 | 26 | 47 | View |
| Treatment Period-PF-06651600 | Participants received PF-06651600 200 mg tablets QD for a 4-week induction period followed by PF-06651600 50 mg tablets QD for a 20-week maintenance period. | 0 | None | 0 | 48 | 23 | 48 | View |
| SBE-Retreated PF-06651600 Responders in Withdrawal Segment | Participants initially treated with PF-06651600 in the Initial 24- Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600. This arm described AEs for retreated responders within withdrawal Segment. | 0 | None | 0 | 14 | 3 | 14 | View |
| Cross Over Extension-PF-06651600 | Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period | 0 | None | 0 | 5 | 4 | 5 | View |
| Cross Over Extension-PF-06700841 | Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period | 0 | None | 1 | 18 | 8 | 18 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rhabdomyolysis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Gastroenteritis salmonella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Rhabdomyolysis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.0 | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.0 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Glomerular filtration rate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Liver function test increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Chest injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Acute sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Pharyngitis streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Sinusitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Soft tissue infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Tinea versicolour | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v22.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Lip oedema | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v22.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.0 | View |
| Ventricular extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.0 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Aphthous ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Hordeolum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Skin laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Torticollis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.0 | View |
| Hidradenitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Eyelids pruritus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v22.0 | View |
| Arthritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Bartholin's abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Orchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Blood potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Depressed level of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Papulopustular rosacea | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Pseudofolliculitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Seborrhoeic dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Urticaria papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Respiratory disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| IgA nephropathy | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.0 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.0 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.0 | View |
| Aggression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Nerve compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Taste disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.0 | View |
| Dermatitis atopic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Keratosis pilaris | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Madarosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |