Trial Outcomes & Findings for Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy (NCT NCT00581555)
NCT ID: NCT00581555
Last Updated: 2012-04-23
Results Overview
PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
Randomization to Week 24.
Results posted on
2012-04-23
Participant Flow
Participant milestones
| Measure |
Placebo
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
58
|
|
Overall Study
COMPLETED
|
19
|
38
|
|
Overall Study
NOT COMPLETED
|
43
|
20
|
Reasons for withdrawal
| Measure |
Placebo
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
18
|
9
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Other reasons
|
16
|
4
|
Baseline Characteristics
Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=62 Participants
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=58 Participants
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
41.50 years
STANDARD_DEVIATION 12.97 • n=5 Participants
|
41.78 years
STANDARD_DEVIATION 9.86 • n=7 Participants
|
41.63 years
STANDARD_DEVIATION 11.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
PASI score
|
19.35 units on scale
STANDARD_DEVIATION 6.98 • n=5 Participants
|
20.19 units on scale
STANDARD_DEVIATION 7.76 • n=7 Participants
|
19.74 units on scale
STANDARD_DEVIATION 7.26 • n=5 Participants
|
|
PGA
|
4.07 units on scale
STANDARD_DEVIATION 0.73 • n=5 Participants
|
4.25 units on scale
STANDARD_DEVIATION 0.85 • n=7 Participants
|
4.15 units on scale
STANDARD_DEVIATION 0.78 • n=5 Participants
|
|
DLQI score
|
11.26 units on scale
STANDARD_DEVIATION 6.30 • n=5 Participants
|
11.20 units on scale
STANDARD_DEVIATION 7.22 • n=7 Participants
|
11.23 units on scale
STANDARD_DEVIATION 6.72 • n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Week 24.Population: Intent-To-Treat (ITT) population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=40 Participants
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)
|
2.9 scores on a scale
Interval 1.0 to 4.8
|
-1.8 scores on a scale
Interval -3.5 to 0.0
|
SECONDARY outcome
Timeframe: Randomization to Week 24.Population: ITT population: included all randomized participants. n equals number of participants with evaluable data.
PASI AUC = Area under the curve from randomization (Week 6) to Week 24.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=58 Participants
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
PASI Area Under the Curve (AUC) Between Randomization and Week 24
Week 8 (n= 59, 56)
|
20.7 scores on a scale * weeks
Standard Error 5.2
|
20.7 scores on a scale * weeks
Standard Error 5.4
|
|
PASI Area Under the Curve (AUC) Between Randomization and Week 24
Week 10 (n= 55, 55)
|
7.0 scores on a scale * weeks
Standard Error 5.3
|
5.0 scores on a scale * weeks
Standard Error 5.4
|
|
PASI Area Under the Curve (AUC) Between Randomization and Week 24
Week 12 (n= 52, 55)
|
6.7 scores on a scale * weeks
Standard Error 5.3
|
4.4 scores on a scale * weeks
Standard Error 5.4
|
|
PASI Area Under the Curve (AUC) Between Randomization and Week 24
Week 16 (n= 45, 49)
|
17.5 scores on a scale * weeks
Standard Error 5.4
|
10.8 scores on a scale * weeks
Standard Error 5.4
|
|
PASI Area Under the Curve (AUC) Between Randomization and Week 24
Week 20 (n= 29, 45)
|
33.6 scores on a scale * weeks
Standard Error 5.6
|
17.5 scores on a scale * weeks
Standard Error 5.5
|
|
PASI Area Under the Curve (AUC) Between Randomization and Week 24
Week 24 (n= 21,40)
|
54.8 scores on a scale * weeks
Standard Error 5.8
|
24.3 scores on a scale * weeks
Standard Error 5.5
|
SECONDARY outcome
Timeframe: Randomization to Week 24.Population: ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=40 Participants
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
Change From Randomization in PGA Score to Week 24
|
0.9 scores on a scale
Interval 0.4 to 1.3
|
0.2 scores on a scale
Interval -0.2 to 0.6
|
SECONDARY outcome
Timeframe: Randomization to Week 24.Population: ITT population: that included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
Relapse was defined as the loss of 50% improvement in PASI.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=58 Participants
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization
|
63.77 Percentage of participants
|
36.23 Percentage of participants
|
SECONDARY outcome
Timeframe: Randomization to Week 24.Population: ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=58 Participants
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
Probability of Being Relapse Free During the 24 Weeks After Randomization
Week 4
|
0.93 probability of relapse free
|
0.91 probability of relapse free
|
|
Probability of Being Relapse Free During the 24 Weeks After Randomization
Week 8
|
0.84 probability of relapse free
|
0.84 probability of relapse free
|
|
Probability of Being Relapse Free During the 24 Weeks After Randomization
Week 12
|
0.44 probability of relapse free
|
0.69 probability of relapse free
|
|
Probability of Being Relapse Free During the 24 Weeks After Randomization
Week 16
|
0.34 probability of relapse free
|
0.60 probability of relapse free
|
|
Probability of Being Relapse Free During the 24 Weeks After Randomization
Week 20
|
0.22 probability of relapse free
|
0.58 probability of relapse free
|
|
Probability of Being Relapse Free During the 24 Weeks After Randomization
Week 24
|
0.17 probability of relapse free
|
0.58 probability of relapse free
|
SECONDARY outcome
Timeframe: Randomization to Week 24.Population: ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
Percent improvement in PASI score was calculated from Week 6 to Week 24.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=38 Participants
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
Percent (%) Change of PASI Score From Randomization to Week 24
|
121.9 percent change
Interval 59.9 to 183.9
|
-13.3 percent change
Interval -68.4 to 41.8
|
SECONDARY outcome
Timeframe: Randomization to Week 24.Population: ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=40 Participants
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
Change From Randomization in DLQI to Week 24
|
2.0 scores on a scale
Interval -0.4 to 4.3
|
-0.4 scores on a scale
Interval -2.5 to 1.7
|
SECONDARY outcome
Timeframe: Baseline to Week 24.Population: ITT population: included all randomized participants. n equals number of participants with evaluable data
DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=58 Participants
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
DLQI at Each Visit From Baseline
Week 2 (n= 28, 30)
|
4.1 scores on a scale
Standard Error 0.9
|
4.0 scores on a scale
Standard Error 0.9
|
|
DLQI at Each Visit From Baseline
Week 4 (n= 25, 22)
|
3.0 scores on a scale
Standard Error 0.9
|
4.0 scores on a scale
Standard Error 0.9
|
|
DLQI at Each Visit From Baseline
Week 6 (n= 8, 3)
|
1.5 scores on a scale
Standard Error 1.2
|
1.9 scores on a scale
Standard Error 1.9
|
|
DLQI at Each Visit From Baseline
Week 8 (n= 58, 55)
|
1.6 scores on a scale
Standard Error 0.6
|
1.6 scores on a scale
Standard Error 0.7
|
|
DLQI at Each Visit From Baseline
Week 10 (n= 56, 54)
|
1.7 scores on a scale
Standard Error 0.6
|
1.0 scores on a scale
Standard Error 0.7
|
|
DLQI at Each Visit From Baseline
Week 12 (n= 52, 54)
|
2.0 scores on a scale
Standard Error 0.7
|
1.0 scores on a scale
Standard Error 0.7
|
|
DLQI at Each Visit From Baseline
Week 16 (n= 44, 48)
|
5.5 scores on a scale
Standard Error 0.7
|
2.8 scores on a scale
Standard Error 0.7
|
|
DLQI at Each Visit From Baseline
Week 20 (n= 29, 44)
|
6.2 scores on a scale
Standard Error 0.8
|
3.3 scores on a scale
Standard Error 0.7
|
|
DLQI at Each Visit From Baseline
Week 24 (n= 20, 40)
|
6.1 scores on a scale
Standard Error 10.9
|
3.6 scores on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline to Week 24.Population: ITT population: included all randomized participants.n equals number of participants with evaluable data for this outcome measure.
Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=58 Participants
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
Percentage of Rebound Effects
|
26.67 percentage of participants
|
0.00 percentage of participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Etanercept
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=62 participants at risk
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=58 participants at risk
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.6%
1/62
|
0.00%
0/58
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/62
|
3.4%
2/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/62
|
1.7%
1/58
|
Other adverse events
| Measure |
Placebo
n=62 participants at risk
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
|
Etanercept
n=58 participants at risk
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/62
|
1.7%
1/58
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
1/62
|
0.00%
0/58
|
|
Cardiac disorders
Oedema peripheral
|
1.6%
1/62
|
0.00%
0/58
|
|
Congenital, familial and genetic disorders
Inborn error of bilirubin metabolism
|
0.00%
0/62
|
1.7%
1/58
|
|
Congenital, familial and genetic disorders
Odontogenic cyst
|
0.00%
0/62
|
1.7%
1/58
|
|
Ear and labyrinth disorders
Ear pain
|
1.6%
1/62
|
0.00%
0/58
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/62
|
1.7%
1/58
|
|
Eye disorders
Vision blurred
|
1.6%
1/62
|
0.00%
0/58
|
|
Eye disorders
Vitreous detachment
|
1.6%
1/62
|
0.00%
0/58
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/62
|
1.7%
1/58
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
1/62
|
0.00%
0/58
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
8/62
|
13.8%
8/58
|
|
Gastrointestinal disorders
Anal pruritus
|
1.6%
1/62
|
0.00%
0/58
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
4/62
|
0.00%
0/58
|
|
Gastrointestinal disorders
Diarrhoea infectious
|
0.00%
0/62
|
1.7%
1/58
|
|
Gastrointestinal disorders
Dysentery
|
0.00%
0/62
|
1.7%
1/58
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/62
|
1.7%
1/58
|
|
Gastrointestinal disorders
Enteritis
|
1.6%
1/62
|
0.00%
0/58
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/62
|
0.00%
0/58
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/62
|
1.7%
1/58
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.6%
1/62
|
1.7%
1/58
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/62
|
1.7%
1/58
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.2%
2/62
|
0.00%
0/58
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/62
|
1.7%
1/58
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
1.6%
1/62
|
0.00%
0/58
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
0.00%
0/62
|
1.7%
1/58
|
|
Gastrointestinal disorders
Gingivitis
|
3.2%
2/62
|
1.7%
1/58
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.6%
1/62
|
0.00%
0/58
|
|
Gastrointestinal disorders
Lip dry
|
1.6%
1/62
|
0.00%
0/58
|
|
Gastrointestinal disorders
Nausea
|
21.0%
13/62
|
12.1%
7/58
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/62
|
1.7%
1/58
|
|
Gastrointestinal disorders
Throat irritation
|
1.6%
1/62
|
0.00%
0/58
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/62
|
3.4%
2/58
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/62
|
1.7%
1/58
|
|
General disorders
Asthenia
|
0.00%
0/62
|
3.4%
2/58
|
|
General disorders
Chest pain
|
0.00%
0/62
|
1.7%
1/58
|
|
General disorders
Fatigue
|
6.5%
4/62
|
8.6%
5/58
|
|
General disorders
Feeling hot
|
3.2%
2/62
|
1.7%
1/58
|
|
General disorders
Feeling of body temperature change
|
3.2%
2/62
|
0.00%
0/58
|
|
General disorders
Hyperpyrexia
|
1.6%
1/62
|
0.00%
0/58
|
|
General disorders
Injection site anaesthesia
|
1.6%
1/62
|
0.00%
0/58
|
|
General disorders
Injection site pain
|
0.00%
0/62
|
1.7%
1/58
|
|
General disorders
Injection site pruritus
|
3.2%
2/62
|
0.00%
0/58
|
|
General disorders
Injection site reaction
|
1.6%
1/62
|
3.4%
2/58
|
|
General disorders
Localised oedema
|
0.00%
0/62
|
1.7%
1/58
|
|
General disorders
Malaise
|
0.00%
0/62
|
1.7%
1/58
|
|
General disorders
Pyrexia
|
1.6%
1/62
|
1.7%
1/58
|
|
Infections and infestations
Ascariasis
|
1.6%
1/62
|
0.00%
0/58
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/62
|
1.7%
1/58
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/62
|
1.7%
1/58
|
|
Infections and infestations
Influenza
|
3.2%
2/62
|
5.2%
3/58
|
|
Infections and infestations
Nasopharyngitis
|
21.0%
13/62
|
19.0%
11/58
|
|
Infections and infestations
Oral herpes
|
1.6%
1/62
|
0.00%
0/58
|
|
Infections and infestations
Pharyngitis
|
1.6%
1/62
|
1.7%
1/58
|
|
Infections and infestations
Rhinitis
|
0.00%
0/62
|
3.4%
2/58
|
|
Infections and infestations
Superinfection
|
1.6%
1/62
|
0.00%
0/58
|
|
Infections and infestations
Tinea cruris
|
1.6%
1/62
|
0.00%
0/58
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/62
|
0.00%
0/58
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/62
|
3.4%
2/58
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/62
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
3.2%
2/62
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/62
|
1.7%
1/58
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/62
|
1.7%
1/58
|
|
Investigations
Blood cholesterol abnormal
|
1.6%
1/62
|
0.00%
0/58
|
|
Investigations
Blood cholesterol increased
|
1.6%
1/62
|
0.00%
0/58
|
|
Investigations
Blood creatinine increased
|
3.2%
2/62
|
6.9%
4/58
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/62
|
1.7%
1/58
|
|
Investigations
Blood pressure increased
|
0.00%
0/62
|
1.7%
1/58
|
|
Investigations
Blood uric acid increased
|
0.00%
0/62
|
1.7%
1/58
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/62
|
5.2%
3/58
|
|
Investigations
Transaminases increased
|
1.6%
1/62
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.6%
1/62
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.6%
1/62
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.6%
1/62
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/62
|
1.7%
1/58
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/62
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
3/62
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
1.6%
1/62
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/62
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/62
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/62
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/62
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.8%
3/62
|
8.6%
5/58
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/62
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.6%
1/62
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
1/62
|
1.7%
1/58
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.6%
1/62
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
2/62
|
8.6%
5/58
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
1.6%
1/62
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/62
|
0.00%
0/58
|
|
Nervous system disorders
Burning sensation
|
1.6%
1/62
|
1.7%
1/58
|
|
Nervous system disorders
Dizziness
|
1.6%
1/62
|
8.6%
5/58
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/62
|
1.7%
1/58
|
|
Nervous system disorders
Headache
|
33.9%
21/62
|
29.3%
17/58
|
|
Nervous system disorders
Hyperaesthesia
|
1.6%
1/62
|
0.00%
0/58
|
|
Nervous system disorders
Insomnia
|
0.00%
0/62
|
1.7%
1/58
|
|
Nervous system disorders
Migraine
|
3.2%
2/62
|
3.4%
2/58
|
|
Nervous system disorders
Paraesthesia
|
16.1%
10/62
|
5.2%
3/58
|
|
Nervous system disorders
Presyncope
|
1.6%
1/62
|
0.00%
0/58
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/62
|
1.7%
1/58
|
|
Nervous system disorders
Vertigo
|
1.6%
1/62
|
0.00%
0/58
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/62
|
1.7%
1/58
|
|
Psychiatric disorders
Depression
|
1.6%
1/62
|
1.7%
1/58
|
|
Psychiatric disorders
Somatoform disorder
|
0.00%
0/62
|
1.7%
1/58
|
|
Renal and urinary disorders
Cystitis
|
3.2%
2/62
|
0.00%
0/58
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/62
|
1.7%
1/58
|
|
Renal and urinary disorders
Renovascular hypertension
|
0.00%
0/62
|
1.7%
1/58
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/62
|
0.00%
0/58
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/62
|
1.7%
1/58
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/62
|
1.7%
1/58
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/62
|
1.7%
1/58
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/62
|
1.7%
1/58
|
|
Reproductive system and breast disorders
Prostatitis
|
1.6%
1/62
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
4.8%
3/62
|
1.7%
1/58
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/62
|
1.7%
1/58
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
2/62
|
1.7%
1/58
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
1.6%
1/62
|
3.4%
2/58
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.2%
2/62
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Alopecia effluvium
|
0.00%
0/62
|
3.4%
2/58
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/62
|
1.7%
1/58
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
1.6%
1/62
|
1.7%
1/58
|
|
Skin and subcutaneous tissue disorders
Hair disorder
|
0.00%
0/62
|
1.7%
1/58
|
|
Skin and subcutaneous tissue disorders
Herpes simplex
|
3.2%
2/62
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
3.2%
2/62
|
6.9%
4/58
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
1.6%
1/62
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Injection site dermatitis
|
0.00%
0/62
|
1.7%
1/58
|
|
Skin and subcutaneous tissue disorders
Injection site rash
|
0.00%
0/62
|
1.7%
1/58
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/62
|
3.4%
2/58
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.2%
2/62
|
5.2%
3/58
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/62
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/62
|
1.7%
1/58
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/62
|
1.7%
1/58
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/62
|
1.7%
1/58
|
|
Surgical and medical procedures
Tooth repair
|
1.6%
1/62
|
0.00%
0/58
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
1/62
|
0.00%
0/58
|
|
Vascular disorders
Essential hypertension
|
3.2%
2/62
|
1.7%
1/58
|
|
Vascular disorders
Hot flush
|
4.8%
3/62
|
3.4%
2/58
|
|
Vascular disorders
Hypertension
|
14.5%
9/62
|
15.5%
9/58
|
|
Vascular disorders
Hypotension
|
1.6%
1/62
|
0.00%
0/58
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/62
|
1.7%
1/58
|
|
Vascular disorders
Migraine with aura
|
1.6%
1/62
|
0.00%
0/58
|
|
Vascular disorders
Secondary hypertension
|
3.2%
2/62
|
1.7%
1/58
|
|
Vascular disorders
Systolic hypertension
|
1.6%
1/62
|
0.00%
0/58
|
|
Vascular disorders
Venous injury
|
1.6%
1/62
|
0.00%
0/58
|
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