Trial Outcomes & Findings for Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis (NCT NCT01100034)

Last Updated: 2019-10-08

Results Overview

Serious infections were defined as any infections those were life-threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalisation. Opportunistic infections of interest included protocol-specified infections due to bacteria: Salmonella bacteremia, Campylobacteriosis, Shigellosis, Mycobacterium tuberculosis, Mycobacterium avium, Mycobacterium kansasii, Syphilis, Pseudomonas aeruginosa, Acinetobacter baumannii, Listeriosis, Nocardiosis, Legionellosis, Actinomycosis, Bartonellosis; Fungal: Aspergillosis, Invasive Candida albicans, Coccidioidomycosis, Cryptococcosis, Histoplasmosis, Blastomycosis, Paracoccidioidomycosis, Sporotrichosis, Penicilliosis, Zygomycosis and Pneumocystosis; Protozoans: Cryptosporidiosis, Isosporiasis, Microsporidiosis, Acanthamoebiasis, Toxoplasmosis, Trypanosomiasis and Leishmaniasis; Viral: Cytomegalovirus, John Cunningham Virus, Disseminated or central nervous system herpes zoster, Kaposi's sarcoma and BK virus.

Recruitment status

COMPLETED

Target enrollment

72 participants

Primary outcome timeframe

Baseline up to 5 years

Results posted on

2019-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Etanercept Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
Overall Study STARTED	72
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Etanercept Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
Overall Study Lost to Follow-up	11
Overall Study Withdrawal of parent/guardian consent	1
Overall Study Withdrawal by Subject	4
Overall Study Sponsor decision	21
Overall Study Participated in another clinical trial	1
Overall Study Participants moved to another hospital	4
Overall Study Site closed due to non-responsiveness	1

Baseline Characteristics

Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etanercept n=72 Participants Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
Age, Continuous	14.5 Years STANDARD_DEVIATION 3.3 • n=93 Participants
Sex: Female, Male Female	35 Participants n=93 Participants
Sex: Female, Male Male	37 Participants n=93 Participants
Race/Ethnicity, Customized White or Caucasian	56 Participants n=93 Participants
Race/Ethnicity, Customized Black	1 Participants n=93 Participants
Race/Ethnicity, Customized Other Asian	2 Participants n=93 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants
Race/Ethnicity, Customized Unknown	11 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline up to 5 years

Outcome measures

Outcome measures
Measure	Etanercept n=32 Participants Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants Serious Infections	0 Participants
Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants Opportunistic Infections of interest	0 Participants
Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants Malignancies	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 28 days after last dose of study drug (up to 61 months)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

Outcome measures

Outcome measures
Measure	Etanercept n=32 Participants Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants Treatment emergent AEs	26 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants Treatment emergent SAEs	3 Participants

PRIMARY outcome

Timeframe: Baseline up to 24 weeks

Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.

Outcome measures

Outcome measures
Measure	Etanercept n=32 Participants Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants	3 Participants

PRIMARY outcome

Timeframe: Week 24 up to Week 216

Population: Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. This outcome measure was planned to be analyzed in prospective participants only. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.

Outcome measures

Outcome measures
Measure	Etanercept n=5 Participants Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants	4 Participants

PRIMARY outcome

Timeframe: Week 24 up to Week 216

Population: Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies the participants evaluable at specific rows.

Participants those who completed the initial treatment period of at least 24 weeks and entered the follow up period, and during the follow up period who required subsequent treatment with etanercept or other systemic therapies were reported.

Outcome measures

Outcome measures
Measure	Etanercept n=28 Participants Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants Etanercept therapies	17.9 percentage of participants
Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants Other Systemic Therapies	26.7 percentage of participants

SECONDARY outcome

Timeframe: Week 24 up to Week 216

Population: Analysis population included all enrolled participants who were documented as having received at least 1 dose of etanercept. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Etanercept n=29 Participants Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period	146.3 weeks Standard Deviation 119.9

Adverse Events

Etanercept

Serious events: 11 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Etanercept n=72 participants at risk Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
Cardiac disorders Angina pectoris	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
General disorders Drug ineffective	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Hepatobiliary disorders Hepatic steatosis	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Chronic tonsillitis	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Nervous system disorders Paraesthesia	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Psychiatric disorders Anorexia nervosa	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Skin and subcutaneous tissue disorders Erythema nodosum	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.00% 0/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Skin and subcutaneous tissue disorders Psoriasis	6.9% 5/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.

Other adverse events

Other adverse events
Measure	Etanercept n=72 participants at risk Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years.
Blood and lymphatic system disorders Lymphadenopathy	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Eye disorders Conjunctivitis	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Gastrointestinal disorders Abdominal pain	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Gastrointestinal disorders Abdominal pain upper	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Gastrointestinal disorders Diarrhoea	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Gastrointestinal disorders Irritable bowel syndrome	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Gastrointestinal disorders Nausea	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Gastrointestinal disorders Vomiting	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
General disorders Drug ineffective	23.6% 17/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
General disorders Injection site erythema	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
General disorders Injection site pain	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
General disorders Injection site reaction	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
General disorders No adverse event	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
General disorders Pyrexia	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Acute tonsillitis	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Bronchitis	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Ear infection	4.2% 3/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Eczema infected	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Enterovirus infection	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Gastroenteritis viral	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Gastrointestinal infection	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Herpes simplex	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Hordeolum	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Infection	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Influenza	6.9% 5/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Nasopharyngitis	25.0% 18/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Otitis media	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Pharyngitis	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Respiratory tract infection	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Respiratory tract infection viral	4.2% 3/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Rhinitis	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Scarlet fever	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Streptococcal infection	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Tonsillitis	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Upper respiratory tract infection	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Urinary tract infection	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Infections and infestations Viral infection	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Injury, poisoning and procedural complications Contusion	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Injury, poisoning and procedural complications Excoriation	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Injury, poisoning and procedural complications Muscle rupture	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Injury, poisoning and procedural complications Skeletal injury	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Injury, poisoning and procedural complications Sunburn	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Investigations Alanine aminotransferase increased	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Investigations Eosinophil count increased	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Investigations Liver function test abnormal	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Metabolism and nutrition disorders Hypercholesterolaemia	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Musculoskeletal and connective tissue disorders Exostosis	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Musculoskeletal and connective tissue disorders Myalgia	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Nervous system disorders Headache	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Nervous system disorders Hypoaesthesia	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Nervous system disorders Migraine	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Nervous system disorders Transient global amnesia	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Pregnancy, puerperium and perinatal conditions Pregnancy	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Psychiatric disorders Somatoform disorder neurologic	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Renal and urinary disorders Proteinuria	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Respiratory, thoracic and mediastinal disorders Cough	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.2% 3/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Skin and subcutaneous tissue disorders Acne	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Skin and subcutaneous tissue disorders Erythema	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Skin and subcutaneous tissue disorders Psoriasis	2.8% 2/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Skin and subcutaneous tissue disorders Vitiligo	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.
Vascular disorders Venous thrombosis	1.4% 1/72 • Baseline up to 28 days after last dose of study drug (up to 61 months) Same event may appear as both an AE and 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 study.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER