Trial Outcomes & Findings for Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists (NCT NCT00293709)
NCT ID: NCT00293709
Last Updated: 2014-02-26
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Recruitment status
COMPLETED
Target enrollment
129 participants
Primary outcome timeframe
Baseline up to Week 52
Results posted on
2014-02-26
Participant Flow
Participant milestones
| Measure |
Participants With Psoriatic Arthritis
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Overall Study
STARTED
|
149
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
47
|
Reasons for withdrawal
| Measure |
Participants With Psoriatic Arthritis
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Overall Study
Other
|
47
|
Baseline Characteristics
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists
Baseline characteristics by cohort
| Measure |
Participants With Psoriatic Arthritis
n=149 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: Safety analysis set included all participants who were enrolled in this study.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Outcome measures
| Measure |
Participants With Psoriatic Arthritis
n=149 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
|
24.2 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Efficacy analysis set included all participants who were greater than (\>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Outcome measures
| Measure |
Participants With Psoriatic Arthritis
n=146 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52
Baseline (n=146)
|
24.5 percentage of BSA
Standard Deviation 22.6
|
|
Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52
Change at Week 52 (n=99)
|
-17.8 percentage of BSA
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
PASI: combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections (head, arms, trunk, and legs); each area was scored by itself and scores were 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\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4; total score ranged from 0 (no disease) to 72 (maximal disease).
Outcome measures
| Measure |
Participants With Psoriatic Arthritis
n=143 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52
Baseline (n=143)
|
15.1 units on a scale
Standard Deviation 12.7
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52
Change at Week 52 (n=93)
|
-11.8 units on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=\<) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate disease activity and \>5.1 = high disease activity.
Outcome measures
| Measure |
Participants With Psoriatic Arthritis
n=68 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52
Baseline (n=68)
|
5.1 units on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52
Change at Week 52 (n=43)
|
-2.2 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.
Outcome measures
| Measure |
Participants With Psoriatic Arthritis
n=146 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Change From Baseline in Ritchie Index at Week 52
Baseline (n=146)
|
15.8 units on a scale
Standard Deviation 12.8
|
|
Change From Baseline in Ritchie Index at Week 52
Change at Week 52 (n=95)
|
-3.6 units on a scale
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.
Outcome measures
| Measure |
Participants With Psoriatic Arthritis
n=148 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Change From Baseline in Physician Global Assessment of Disease Activity at Week 52
Baseline (n=148)
|
60.4 millimeter
Standard Deviation 22.3
|
|
Change From Baseline in Physician Global Assessment of Disease Activity at Week 52
Change at Week 52 (n=102)
|
-35.8 millimeter
Standard Deviation 31.4
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 52Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Number of participants with psoriatic arthritis affecting the nails are reported.
Outcome measures
| Measure |
Participants With Psoriatic Arthritis
n=147 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Number of Participants With Nail Involvement
Baseline (n=147)
|
103 participants
|
|
Number of Participants With Nail Involvement
Week 12 (n=131)
|
81 participants
|
|
Number of Participants With Nail Involvement
Week 52 (n=100)
|
50 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Outcome measures
| Measure |
Participants With Psoriatic Arthritis
n=115 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Change From Baseline in C-reactive Protein (CRP) at Week 52
Baseline (n=115)
|
1.6 milligram per deciliter (mg/dL)
Standard Deviation 3.0
|
|
Change From Baseline in C-reactive Protein (CRP) at Week 52
Change at Week 52 (n=69)
|
-0.6 milligram per deciliter (mg/dL)
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.
Outcome measures
| Measure |
Participants With Psoriatic Arthritis
n=147 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Change From Baseline in Patient Assessment of Itching at Week 52
Baseline (n=147)
|
44.0 units on a scale
Standard Deviation 29.2
|
|
Change From Baseline in Patient Assessment of Itching at Week 52
Change at Week 52 (n=98)
|
-26.1 units on a scale
Standard Deviation 34.2
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.
Outcome measures
| Measure |
Participants With Psoriatic Arthritis
n=147 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Change From Baseline in Patient Assessment of Pain at Week 52
Baseline (n=147)
|
60.0 units on a scale
Standard Deviation 27.1
|
|
Change From Baseline in Patient Assessment of Pain at Week 52
Change at Week 52 (n=98)
|
-37.5 units on a scale
Standard Deviation 33.8
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Efficacy analysis set included all participants who were \>18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts : physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.
Outcome measures
| Measure |
Participants With Psoriatic Arthritis
n=142 Participants
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52
Baseline: Physical component (n=142)
|
33.5 units on a scale
Standard Deviation 9.2
|
|
Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52
Baseline: Mental component (n=142)
|
40.5 units on a scale
Standard Deviation 11.5
|
|
Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52
Change at Week 52: Physical component (n=89)
|
11.7 units on a scale
Standard Deviation 10.3
|
|
Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52
Change at Week 52: Mental component (n=89)
|
9.4 units on a scale
Standard Deviation 11.9
|
Adverse Events
Participants With Psoriatic Arthritis
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Psoriatic Arthritis
n=149 participants at risk
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pleural infection
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Participants With Psoriatic Arthritis
n=149 participants at risk
Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
|
|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pain
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
3/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Condition aggravated
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Influenza like illness
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site erythema
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site inflammation
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site pruritus
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site reaction
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Malaise
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacteraemia
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Genital herpes
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes virus infection
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infection
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
8/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rhinitis
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinobronchitis
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tinea versicolour
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tonsillitis
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth abscess
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
3/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Arthroscopy
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Platelet count decreased
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Serum ferritin decreased
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Transaminases increased
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Burning sensation
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Migraine
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Alcoholism
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
3/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.3%
2/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
3/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Ligament operation
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Blood pressure fluctuation
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
0.67%
1/149
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
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