Trial Outcomes & Findings for The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis (NCT NCT02570750)
NCT ID: NCT02570750
Last Updated: 2018-12-20
Results Overview
PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Recruitment status
COMPLETED
Target enrollment
183 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2018-12-20
Participant Flow
Participant milestones
| Measure |
Etanercept: Non Smokers
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per summary of product characteristics (SmPC), were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Etanercept: Smokers
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
73
|
|
Overall Study
COMPLETED
|
96
|
68
|
|
Overall Study
NOT COMPLETED
|
14
|
5
|
Reasons for withdrawal
| Measure |
Etanercept: Non Smokers
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per summary of product characteristics (SmPC), were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Etanercept: Smokers
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
|---|---|---|
|
Overall Study
Inclusion/exclusion criteria deviation
|
1
|
0
|
|
Overall Study
Protocol deviation
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Adverse Event
|
2
|
1
|
Baseline Characteristics
The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Baseline characteristics by cohort
| Measure |
Etanercept: Non Smokers
n=96 Participants
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Etanercept: Smokers
n=68 Participants
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Per protocol set included all treated participants.
PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Outcome measures
| Measure |
Etanercept: Non Smokers
n=96 Participants
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Etanercept: Smokers
n=68 Participants
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
Change at Week 24
|
16.5 units on a scale
Standard Deviation 5.2
|
17.1 units on a scale
Standard Deviation 5.4
|
|
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
Baseline
|
23.1 units on a scale
Standard Deviation 6.2
|
23.4 units on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Per protocol set included all treated participants.
The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Outcome measures
| Measure |
Etanercept: Non Smokers
n=96 Participants
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Etanercept: Smokers
n=68 Participants
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI)
Baseline
|
22.0 units on a scale
Standard Deviation 5.3
|
21.7 units on a scale
Standard Deviation 4.8
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI)
Change at Week 12
|
12.3 units on a scale
Standard Deviation 6.0
|
12.8 units on a scale
Standard Deviation 4.9
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI)
Change at Week 24
|
16.4 units on a scale
Standard Deviation 6.0
|
16.8 units on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Week 12, 24Population: Per protocol set included all treated participants.
PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline.
Outcome measures
| Measure |
Etanercept: Non Smokers
n=96 Participants
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Etanercept: Smokers
n=68 Participants
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
|---|---|---|
|
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24
Week 24
|
45.8 percentage of participants
|
44.1 percentage of participants
|
|
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24
Week 12
|
9.3 percentage of participants
|
4.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12, 24Population: Per protocol set included all treated participants.
PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI50 response was defined as at least a 50% reduction in PASI relative to baseline.
Outcome measures
| Measure |
Etanercept: Non Smokers
n=96 Participants
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Etanercept: Smokers
n=68 Participants
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
|---|---|---|
|
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24
Week 24
|
97.9 percentage of participants
|
98.5 percentage of participants
|
|
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24
Week 12
|
77.0 percentage of participants
|
82.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Per protocol set included all treated participants.
PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Outcome measures
| Measure |
Etanercept: Non Smokers
n=96 Participants
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Etanercept: Smokers
n=68 Participants
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12
|
12.6 units on a scale
Standard Deviation 4.4
|
12.8 units on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24Population: Per protocol set included all treated participants. Here, "N" (overall number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). Participants who had bone marrow index \>30 kilogram per meter square were said to be obese in this outcome measure.
Outcome measures
| Measure |
Etanercept: Non Smokers
n=36 Participants
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Etanercept: Smokers
n=10 Participants
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
|---|---|---|
|
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants
Baseline
|
24.2 units on a scale
Standard Deviation 6.12
|
23.9 units on a scale
Standard Deviation 7.14
|
|
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants
Change at Week 12
|
12.2 units on a scale
Standard Deviation 4.52
|
12.1 units on a scale
Standard Deviation 5.21
|
|
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants
Change at Week 24
|
17.1 units on a scale
Standard Deviation 5.79
|
16.8 units on a scale
Standard Deviation 4.26
|
Adverse Events
Etanercept: Non Smokers
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Etanercept: Smokers
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Etanercept: Non Smokers
n=96 participants at risk
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Etanercept: Smokers
n=68 participants at risk
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
|---|---|---|
|
Infections and infestations
Inflammation at site injection
|
0.00%
0/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
1.5%
1/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
|
Endocrine disorders
Diabetic gangrene
|
1.0%
1/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
0.00%
0/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
|
Nervous system disorders
Cerebellar haematoma
|
1.0%
1/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
0.00%
0/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
1.5%
1/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
|
Immune system disorders
Erytrodermic psoriasis
|
0.00%
0/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
1.5%
1/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
Other adverse events
| Measure |
Etanercept: Non Smokers
n=96 participants at risk
Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
Etanercept: Smokers
n=68 participants at risk
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erytrodermic psoriasis
|
1.0%
1/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
0.00%
0/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
|
General disorders
Injection site erythema
|
0.00%
0/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
1.5%
1/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.0%
1/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
0.00%
0/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
|
Renal and urinary disorders
Proteinuria
|
1.0%
1/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
0.00%
0/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
1.5%
1/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
|
Investigations
Increase of serum transaminases
|
0.00%
0/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
1.5%
1/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/96 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
1.5%
1/68 • Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
|
Additional Information
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