Trial Outcomes & Findings for An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria (NCT NCT01557283)
NCT ID: NCT01557283
Last Updated: 2014-06-30
Results Overview
Average duration of time in weeks for treatment with etanercept was reported.
Recruitment status
COMPLETED
Target enrollment
140 participants
Primary outcome timeframe
Baseline up to end of study (90 weeks)
Results posted on
2014-06-30
Participant Flow
Participant milestones
| Measure |
Etanercept
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
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|---|---|
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Overall Study
STARTED
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140
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Overall Study
COMPLETED
|
96
|
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Overall Study
NOT COMPLETED
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44
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Reasons for withdrawal
| Measure |
Etanercept
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
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|---|---|
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Overall Study
Lost to Follow-up
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7
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Overall Study
Non-responder
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19
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Overall Study
Adverse Event
|
7
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|
Overall Study
Lack of Efficacy
|
1
|
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Overall Study
Non-compliance
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1
|
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Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Participant's weight too high for dose
|
1
|
|
Overall Study
Worsening of psoriasis
|
1
|
|
Overall Study
Other
|
6
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Baseline Characteristics
An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria
Baseline characteristics by cohort
| Measure |
Etanercept
n=138 Participants
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
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|---|---|
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Age, Continuous
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48.83 years
STANDARD_DEVIATION 12.428 • n=93 Participants
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Sex: Female, Male
Female
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48 Participants
n=93 Participants
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Sex: Female, Male
Male
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90 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline up to end of study (90 weeks)Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.
Average duration of time in weeks for treatment with etanercept was reported.
Outcome measures
| Measure |
Etanercept
n=138 Participants
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
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|---|---|
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Number of Weeks of Etanercept Treatment
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48.1874 weeks
Standard Deviation 17.55204
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SECONDARY outcome
Timeframe: Baseline up to end of study (90 weeks)Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
Total duration of time in weeks for which participants discontinued etanercept treatment was reported.
Outcome measures
| Measure |
Etanercept
n=121 Participants
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
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|---|---|
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Number of Weeks of Off-Treatment
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5.5348 weeks
Standard Deviation 10.15699
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SECONDARY outcome
Timeframe: Start and end of cycle 1, 2, 3Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; 'n' signifies participants evaluable for this measure at specified time points.
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (\<) 10%, 2 = 10 to \<30%, 3 = 30 to \<50%, 4 = 50 to \<70%, 5= 70 to \<90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, 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 possible score range: 0= no disease to 72= maximal disease.
Outcome measures
| Measure |
Etanercept
n=136 Participants
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
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|---|---|
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Psoriasis Area and Severity Index (PASI) Score
End of Cycle 1 (n=123)
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6.680 units on a scale
Standard Deviation 7.6061
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Psoriasis Area and Severity Index (PASI) Score
Start of Cycle 2 (n=114)
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6.395 units on a scale
Standard Deviation 6.1129
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Psoriasis Area and Severity Index (PASI) Score
End of Cycle 2 (n=87)
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5.571 units on a scale
Standard Deviation 6.0198
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Psoriasis Area and Severity Index (PASI) Score
End of Cycle 3 (n=25)
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5.468 units on a scale
Standard Deviation 6.2810
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Psoriasis Area and Severity Index (PASI) Score
Start of Cycle 1 (n=136)
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10.913 units on a scale
Standard Deviation 8.6412
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Psoriasis Area and Severity Index (PASI) Score
Start of Cycle 3 (n=81)
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5.504 units on a scale
Standard Deviation 5.3579
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SECONDARY outcome
Timeframe: Start and end of cycle 1, 2, 3Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; 'n' signifies participants evaluable for this measure at specified time points.
Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected.
Outcome measures
| Measure |
Etanercept
n=129 Participants
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
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|---|---|
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Percentage of Body Surface Area (BSA) Affected by Psoriasis
Start of Cycle 1 (n=129)
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14.189 percentage of BSA
Standard Deviation 14.8781
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Percentage of Body Surface Area (BSA) Affected by Psoriasis
End of Cycle 1 (n=115)
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8.016 percentage of BSA
Standard Deviation 10.8758
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Percentage of Body Surface Area (BSA) Affected by Psoriasis
Start of Cycle 2 (n=108)
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7.579 percentage of BSA
Standard Deviation 8.8944
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Percentage of Body Surface Area (BSA) Affected by Psoriasis
End of Cycle 2 (n=84)
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5.361 percentage of BSA
Standard Deviation 5.9864
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Percentage of Body Surface Area (BSA) Affected by Psoriasis
Start of Cycle 3 (n=78)
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5.706 percentage of BSA
Standard Deviation 6.9649
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Percentage of Body Surface Area (BSA) Affected by Psoriasis
End of Cycle 3 (n=28)
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10.221 percentage of BSA
Standard Deviation 16.3993
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SECONDARY outcome
Timeframe: Baseline up to end of study (90 weeks)Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.
Number of participants who discontinued etanercept before completing the study was reported.
Outcome measures
| Measure |
Etanercept
n=138 Participants
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
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|---|---|
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Number of Participants With Reasons for Treatmant Discontinuation
Participant's weight too high for dose
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1 participants
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Number of Participants With Reasons for Treatmant Discontinuation
Worsening of Psoriasis
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1 participants
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Number of Participants With Reasons for Treatmant Discontinuation
Unspecified
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1 participants
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Number of Participants With Reasons for Treatmant Discontinuation
Non-responders
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19 participants
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Number of Participants With Reasons for Treatmant Discontinuation
Adverse Event
|
7 participants
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|
Number of Participants With Reasons for Treatmant Discontinuation
Lack of Efficacy
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1 participants
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Number of Participants With Reasons for Treatmant Discontinuation
Non-compliance
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1 participants
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Number of Participants With Reasons for Treatmant Discontinuation
Withdrawal by Subject
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1 participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to end of study (90 weeks)Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported.
Outcome measures
| Measure |
Etanercept
n=121 Participants
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
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|---|---|
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Number of Participants Who Received Continuous Treatment
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80 participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to end of study (90 weeks)Population: Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.
Outcome measures
| Measure |
Etanercept
n=121 Participants
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
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|---|---|
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Number of Participants Who Received Intermittent Treatment
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41 participants
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Adverse Events
Etanercept
Serious events: 7 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept
n=138 participants at risk
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
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|---|---|
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Hepatobiliary disorders
Cholecystolithiasis
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Metabolism and nutrition disorders
Obesity and surgery
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0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Paget's disease
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast carcinoma
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection viral
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
Other adverse events
| Measure |
Etanercept
n=138 participants at risk
Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist's discretion.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Gastrointestinal disorders
Diarrhea
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Gastrointestinal disorders
Functional digestive disorders, not elsewhere classified
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
General disorders
Injection site reaction
|
1.4%
2/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
General disorders
Leg edema
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
General disorders
Face edema
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
General disorders
Fatigue
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Hepatobiliary disorders
Hepatic dysfunction NOS
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Immune system disorders
Allergic reaction
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Infections and infestations
Sinusitis
|
1.4%
2/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Infections and infestations
Rhinopharyngitis
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Infections and infestations
Bronchitis
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Investigations
Weight loss
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Nervous system disorders
Cluster headache
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Nervous system disorders
Headache
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
4.3%
6/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
1.4%
2/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Keratoacanthoma
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Ankle ulcer
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Surgical and medical procedures
Plastic operation on nose
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Vascular disorders
Hypotension
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
|
Vascular disorders
Blood pressure high
|
0.72%
1/138
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. All participants included in per protocol population were evaluable for safety.
|
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