Trial Outcomes & Findings for Pediatric Open-Label Extension Study of Etanercept in Patients With Plaque Psoriasis (NCT NCT00141921)
NCT ID: NCT00141921
Last Updated: 2017-10-05
Results Overview
A serious adverse events is any AE that * is fatal * is life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity). An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
COMPLETED
PHASE3
182 participants
264 Weeks
2017-10-05
Participant Flow
This study was designed to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe plaque psoriasis who participated in Study 20030211 (NCT00078819). The study was conducted at 38 sites in the United States and Canada.
Results reported below are from the main analysis performed at year 5 (264 weeks).
Participant milestones
| Measure |
Etanercept
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Overall Study
STARTED
|
182
|
|
Overall Study
Received Treatment
|
181
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
141
|
Reasons for withdrawal
| Measure |
Etanercept
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Overall Study
Remain on Study
|
28
|
|
Overall Study
Withdrawal by Subject
|
42
|
|
Overall Study
Lost to Follow-up
|
19
|
|
Overall Study
Noncompliance
|
17
|
|
Overall Study
Disease Progression
|
7
|
|
Overall Study
Protocol Deviation
|
7
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Administrative Decision
|
2
|
|
Overall Study
Pregnancy
|
4
|
|
Overall Study
Ineligibility Determined
|
2
|
|
Overall Study
Other
|
8
|
Baseline Characteristics
Pediatric Open-Label Extension Study of Etanercept in Patients With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Etanercept
n=182 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Age, Continuous
|
12.8 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
138 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 264 WeeksPopulation: Participants who received at least one dose of investigational product.
A serious adverse events is any AE that * is fatal * is life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity). An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
Outcome measures
| Measure |
Etanercept
n=181 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
161 participants
|
|
Number of Participants With Adverse Events
Non-infectious adverse events
|
149 participants
|
|
Number of Participants With Adverse Events
Infections
|
140 participants
|
|
Number of Participants With Adverse Events
Grade 3 non-infectious adverse events
|
14 participants
|
|
Number of Participants With Adverse Events
Grade 3 infections
|
5 participants
|
|
Number of Participants With Adverse Events
Serious non-infectious adverse events
|
5 participants
|
|
Number of Participants With Adverse Events
Serious infections
|
2 participants
|
|
Number of Participants With Adverse Events
Non-infectious AEs leading to study withdrawal
|
5 participants
|
|
Number of Participants With Adverse Events
Infections leading to withdrawal from study
|
1 participants
|
|
Number of Participants With Adverse Events
Injection site reactions
|
16 participants
|
|
Number of Participants With Adverse Events
Deaths
|
0 participants
|
SECONDARY outcome
Timeframe: 264 weeksPopulation: Participants who received at least one dose of investigational product.
An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
Outcome measures
| Measure |
Etanercept
n=181 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Number of Participants With Injection Site Reactions
Any injection site reaction
|
16 participants
|
|
Number of Participants With Injection Site Reactions
Injection site erythema
|
6 participants
|
|
Number of Participants With Injection Site Reactions
Injection site reaction
|
4 participants
|
|
Number of Participants With Injection Site Reactions
Injection site pruritus
|
3 participants
|
|
Number of Participants With Injection Site Reactions
Injection site haematoma
|
2 participants
|
|
Number of Participants With Injection Site Reactions
Injection site swelling
|
2 participants
|
|
Number of Participants With Injection Site Reactions
Injection site discolouration
|
1 participants
|
|
Number of Participants With Injection Site Reactions
Injection site irritation
|
1 participants
|
|
Number of Participants With Injection Site Reactions
Injection site pain
|
1 participants
|
SECONDARY outcome
Timeframe: 264 weeksPopulation: Participants who received at least one dose of investigational product.
The exposure adjusted event rate for a given event in a given time period is defined as the number of events reported in the given time period divided by total patient-years on investigational product during the period. Exposure-adjusted event rate per 100 patient years = total number of events / patient years \* 100. Multiple occurrences of the same event for a participant were counted as multiple events.
Outcome measures
| Measure |
Etanercept
n=181 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Exposure-adjusted Adverse Event Rates
All adverse events
|
215.8 events per 100 patient years
|
|
Exposure-adjusted Adverse Event Rates
Non-infectious Adverse Events
|
115.9 events per 100 patient years
|
|
Exposure-adjusted Adverse Event Rates
Infections
|
97.3 events per 100 patient years
|
|
Exposure-adjusted Adverse Event Rates
Injection Site Reactions
|
2.6 events per 100 patient years
|
SECONDARY outcome
Timeframe: 264 weeksPopulation: Participants who received at least one dose of investigational product.
Outcome measures
| Measure |
Etanercept
n=181 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
|
0 participants
|
SECONDARY outcome
Timeframe: 264 weeksPopulation: Participants who received at least one dose of investigational product.
The severity assessment for adverse events and infections (not including injection site reaction) used the Common Toxicity Criteria (CTC) Version 2.0, where Grade 1= Mild - aware of sign or symptom, but easily tolerated; Grade 2= Moderate - discomfort enough to cause interference with usual activity; Grade 3 = Severe - incapacitating with inability to work or do usual activity; Grade 4= Life-threatening - refers to an event in which the patient was, in the view of the investigator, at risk of immediate death at the time of event; Grade 5 = Fatal.
Outcome measures
| Measure |
Etanercept
n=181 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Number of Participants With Grade 3 and 4 Laboratory Toxicities
Grade 3 high creatinine
|
1 participants
|
|
Number of Participants With Grade 3 and 4 Laboratory Toxicities
Grade 3 high hemoglobin
|
1 participants
|
|
Number of Participants With Grade 3 and 4 Laboratory Toxicities
Grade 3 low hemoglobin
|
1 participants
|
|
Number of Participants With Grade 3 and 4 Laboratory Toxicities
Grade 3 high alanine aminotransferase
|
1 participants
|
|
Number of Participants With Grade 3 and 4 Laboratory Toxicities
Grade 3 high white blood cells
|
1 participants
|
|
Number of Participants With Grade 3 and 4 Laboratory Toxicities
Any grade 4 toxicity
|
0 participants
|
SECONDARY outcome
Timeframe: 264 weeksPopulation: Participants who received at least one dose of investigational product and had a post-baseline antibody result.
Binding antibodies to etanercept were detected using an anti-etanercept immunoassay. The positive samples in the immunoassay were further analyzed for the presence of neutralizing antibodies using a bioassay. Participants who developed anti-etanercept antibodies are those who were antibody positive post-baseline with a negative or no result at baseline.
Outcome measures
| Measure |
Etanercept
n=169 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Number of Participants Who Developed Anti-etanercept Antibodies
Binding antibody positive
|
18 participants
|
|
Number of Participants Who Developed Anti-etanercept Antibodies
Neutralizing antibody positive
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264Population: Participants who received at least one dose of investigational product and with available data at each time point.
A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Outcome measures
| Measure |
Etanercept
n=181 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
Week 12 (N = 181)
|
89.5 percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
Week 48 (N = 168)
|
89.3 percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
Week 96 (N = 138)
|
89.1 percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
Week 144 (N = 114)
|
88.6 percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
Week 192 (n = 92)
|
87.0 percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
Week 240 (N = 74)
|
91.9 percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
Week 264 (N = 66)
|
87.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264Population: Participants who received at least one dose of investigational product with available data at each time point.
A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Outcome measures
| Measure |
Etanercept
n=181 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percentage of Participants With a PASI 75 Response
Week 12 (N = 181)
|
67.4 percentage of participants
|
|
Percentage of Participants With a PASI 75 Response
Week 48 (N = 168)
|
67.3 percentage of participants
|
|
Percentage of Participants With a PASI 75 Response
Week 96 (N = 138)
|
60.9 percentage of participants
|
|
Percentage of Participants With a PASI 75 Response
Week 144 (N = 114)
|
62.3 percentage of participants
|
|
Percentage of Participants With a PASI 75 Response
Week 192 (n = 92)
|
69.6 percentage of participants
|
|
Percentage of Participants With a PASI 75 Response
Week 240 (N = 74)
|
64.9 percentage of participants
|
|
Percentage of Participants With a PASI 75 Response
Week 264 (N = 66)
|
63.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264Population: Participants who received at least one dose of investigational product with available data at each time point.
A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Outcome measures
| Measure |
Etanercept
n=181 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percentage of Participants With a PASI 90 Response
Week 12 (N = 181)
|
35.4 percentage of participants
|
|
Percentage of Participants With a PASI 90 Response
Week 48 (N = 168)
|
32.7 percentage of participants
|
|
Percentage of Participants With a PASI 90 Response
Week 96 (N = 138)
|
29.7 percentage of participants
|
|
Percentage of Participants With a PASI 90 Response
Week 144 (N = 114)
|
28.1 percentage of participants
|
|
Percentage of Participants With a PASI 90 Response
Week 192 (n = 92)
|
35.9 percentage of participants
|
|
Percentage of Participants With a PASI 90 Response
Week 240 (N = 74)
|
36.5 percentage of participants
|
|
Percentage of Participants With a PASI 90 Response
Week 264 (N = 66)
|
28.8 percentage of participants
|
SECONDARY outcome
Timeframe: Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264Population: Participants who received at least one dose of investigational product with available data at each time point.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Outcome measures
| Measure |
Etanercept
n=181 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percent Improvement From Study 20030211 Baseline in PASI Score
Study 20050111 baseline (N = 179)
|
74.429 percent improvement
Standard Deviation 22.146
|
|
Percent Improvement From Study 20030211 Baseline in PASI Score
Week 12 (N = 181)
|
78.286 percent improvement
Standard Deviation 21.079
|
|
Percent Improvement From Study 20030211 Baseline in PASI Score
Week 48 (N = 168)
|
77.546 percent improvement
Standard Deviation 20.682
|
|
Percent Improvement From Study 20030211 Baseline in PASI Score
Week 96 (N = 138)
|
75.355 percent improvement
Standard Deviation 24.139
|
|
Percent Improvement From Study 20030211 Baseline in PASI Score
Week 144 (N = 114)
|
75.052 percent improvement
Standard Deviation 23.839
|
|
Percent Improvement From Study 20030211 Baseline in PASI Score
Week 192 (n = 92)
|
77.815 percent improvement
Standard Deviation 23.965
|
|
Percent Improvement From Study 20030211 Baseline in PASI Score
Week 240 (N = 74)
|
78.924 percent improvement
Standard Deviation 23.497
|
|
Percent Improvement From Study 20030211 Baseline in PASI Score
Week 264 (N = 66)
|
74.605 percent improvement
Standard Deviation 29.327
|
SECONDARY outcome
Timeframe: Weeks 12, 48, 96, 144, 192, 240 and 264Population: Participants who received at least one dose of investigational product with available data at each time point.
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Outcome measures
| Measure |
Etanercept
n=181 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
Week 264 (N = 66)
|
37.9 percentage of participants
|
|
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
Week 12 (N = 181)
|
53.6 percentage of participants
|
|
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
Week 48 (N = 168)
|
48.8 percentage of participants
|
|
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
Week 96 (N = 139)
|
47.5 percentage of participants
|
|
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
Week 144 (N = 114)
|
45.6 percentage of participants
|
|
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
Week 192 (n = 92)
|
47.8 percentage of participants
|
|
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
Week 240 (N = 74)
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264Population: Participants who received at least one dose of investigational product with baseline data, and with available data at each time point.
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. If participants were ≥ 13 years old, the text instrument was completed by the participants themselves. Participants ≥ 8 but \< 13 years old used the cartoon version of the instrument and participants ≤ 7 years old used the cartoon version of the instrument completed with help from the parents or caregivers. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Outcome measures
| Measure |
Etanercept
n=173 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Study 20050111 baseline (N = 164)
|
59.492 percent improvement
Standard Deviation 73.501
|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Week 24 (N = 155)
|
54.978 percent improvement
Standard Deviation 69.744
|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Week 48 (N = 148)
|
59.229 percent improvement
Standard Deviation 65.259
|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Week 72 (N = 136)
|
57.549 percent improvement
Standard Deviation 79.389
|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Week 96 (N = 127)
|
61.084 percent improvement
Standard Deviation 66.169
|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Week 120 (N = 105)
|
64.059 percent improvement
Standard Deviation 75.298
|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Week 144 (N = 103)
|
69.732 percent improvement
Standard Deviation 42.008
|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Week 168 (N = 93)
|
67.531 percent improvement
Standard Deviation 42.261
|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Week 192 (N = 81)
|
65.622 percent improvement
Standard Deviation 53.359
|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Week 216 (N = 70)
|
76.121 percent improvement
Standard Deviation 43.217
|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Week 240 (N = 64)
|
73.631 percent improvement
Standard Deviation 54.704
|
|
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Week 264 (N = 56)
|
63.291 percent improvement
Standard Deviation 63.555
|
SECONDARY outcome
Timeframe: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Symptoms and Feelings Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Outcome measures
| Measure |
Etanercept
n=173 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Study 20050111 baseline (N = 165)
|
54.869 percent improvement
Standard Deviation 56.213
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Week 24 (N = 155)
|
55.366 percent improvement
Standard Deviation 64.039
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Week 48 (N = 149)
|
53.792 percent improvement
Standard Deviation 65.857
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Week 72 (N = 136)
|
51.005 percent improvement
Standard Deviation 68.117
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Week 96 (N = 128)
|
55.430 percent improvement
Standard Deviation 57.430
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Week 120 (N = 105)
|
53.302 percent improvement
Standard Deviation 67.555
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Week 144 (N = 104)
|
56.250 percent improvement
Standard Deviation 58.194
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Week 168 (N = 94)
|
58.901 percent improvement
Standard Deviation 49.431
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Week 192 (N = 81)
|
55.700 percent improvement
Standard Deviation 56.352
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Week 216 (N = 71)
|
71.056 percent improvement
Standard Deviation 41.396
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Week 240 (N = 65)
|
67.538 percent improvement
Standard Deviation 43.418
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Week 264 (N = 57)
|
56.725 percent improvement
Standard Deviation 52.965
|
SECONDARY outcome
Timeframe: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Leisure Score includes 3 questions and ranges from 0 to 9, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Outcome measures
| Measure |
Etanercept
n=173 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Study 20050111 baseline (N = 165)
|
51.088 percent improvement
Standard Deviation 52.612
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Week 24 (N = 156)
|
50.546 percent improvement
Standard Deviation 58.606
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Week 48 (N = 148)
|
51.792 percent improvement
Standard Deviation 61.204
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Week 72 (N = 136)
|
50.792 percent improvement
Standard Deviation 70.769
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Week 96 (N = 129)
|
48.686 percent improvement
Standard Deviation 68.482
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Week 120 (N = 105)
|
59.031 percent improvement
Standard Deviation 49.472
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Week 144 (N = 104)
|
57.125 percent improvement
Standard Deviation 54.284
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Week 168 (N = 94)
|
55.198 percent improvement
Standard Deviation 52.141
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Week 192 (N = 81)
|
47.989 percent improvement
Standard Deviation 72.947
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Week 216 (N = 71)
|
58.545 percent improvement
Standard Deviation 60.440
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Week 240 (N = 64)
|
55.727 percent improvement
Standard Deviation 64.420
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Week 264 (N = 56)
|
50.072 percent improvement
Standard Deviation 62.049
|
SECONDARY outcome
Timeframe: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI School or Holidays Score includes 1 question (How much did your skin problem effect your school work/holiday plans over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Outcome measures
| Measure |
Etanercept
n=173 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Study 20050111 baseline (N = 165)
|
31.616 percent improvement
Standard Deviation 51.981
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Week 24 (N = 156)
|
32.585 percent improvement
Standard Deviation 52.750
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Week 48 (N = 148)
|
36.149 percent improvement
Standard Deviation 51.778
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Week 72 (N = 133)
|
29.825 percent improvement
Standard Deviation 53.025
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Week 96 (N = 129)
|
29.457 percent improvement
Standard Deviation 55.805
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Week 120 (N = 105)
|
32.063 percent improvement
Standard Deviation 55.166
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Week 144 (N = 105)
|
33.333 percent improvement
Standard Deviation 48.371
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Week 168 (N = 94)
|
32.979 percent improvement
Standard Deviation 50.563
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Week 192 (N = 81)
|
31.070 percent improvement
Standard Deviation 52.886
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Week 216 (N = 71)
|
35.211 percent improvement
Standard Deviation 48.103
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Week 240 (N = 65)
|
26.923 percent improvement
Standard Deviation 56.649
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Week 264 (N = 57)
|
27.193 percent improvement
Standard Deviation 51.815
|
SECONDARY outcome
Timeframe: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Personal Relationships Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Outcome measures
| Measure |
Etanercept
n=173 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Study 20050111 baseline (N = 166)
|
45.452 percent improvement
Standard Deviation 65.038
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Week 24 (N = 156)
|
49.797 percent improvement
Standard Deviation 59.328
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Week 48 (N = 149)
|
50.895 percent improvement
Standard Deviation 60.179
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Week 72 (N = 136)
|
54.669 percent improvement
Standard Deviation 54.519
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Week 96 (N = 129)
|
48.346 percent improvement
Standard Deviation 60.414
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Week 120 (N = 105)
|
51.206 percent improvement
Standard Deviation 54.435
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Week 144 (N = 105)
|
50.365 percent improvement
Standard Deviation 49.636
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Week 168 (N = 94)
|
44.557 percent improvement
Standard Deviation 72.287
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Week 192 (N = 81)
|
52.284 percent improvement
Standard Deviation 56.125
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Week 216 (N = 71)
|
61.737 percent improvement
Standard Deviation 48.255
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Week 240 (N = 65)
|
56.282 percent improvement
Standard Deviation 52.042
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Week 264 (N = 57)
|
56.140 percent improvement
Standard Deviation 52.481
|
SECONDARY outcome
Timeframe: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Sleep Score includes 1 question (How much has your sleep been affected by your skin problems over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Outcome measures
| Measure |
Etanercept
n=171 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Week 144 (N = 102)
|
41.013 percent improvement
Standard Deviation 50.229
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Week 120 (N = 101)
|
29.538 percent improvement
Standard Deviation 61.503
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Study 20050111 baseline (N = 161)
|
36.646 percent improvement
Standard Deviation 56.851
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Week 24 (N = 153)
|
36.057 percent improvement
Standard Deviation 60.349
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Week 48 (N = 144)
|
31.597 percent improvement
Standard Deviation 56.329
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Week 72 (N = 132)
|
34.596 percent improvement
Standard Deviation 57.390
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Week 96 (N = 127)
|
32.940 percent improvement
Standard Deviation 55.216
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Week 168 (N = 93)
|
37.814 percent improvement
Standard Deviation 49.888
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Week 192 (N = 81)
|
34.774 percent improvement
Standard Deviation 54.658
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Week 216 (N = 71)
|
35.681 percent improvement
Standard Deviation 50.811
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Week 240 (N = 65)
|
39.231 percent improvement
Standard Deviation 48.808
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Week 264 (N = 56)
|
36.012 percent improvement
Standard Deviation 57.890
|
SECONDARY outcome
Timeframe: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264Population: Participants who received at least one dose of investigational product with baseline data and with available data at each time point.
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Treatment Satisfaction Score includes 1 question (How much of a problem has the treatment for your skin been over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value \* 100.
Outcome measures
| Measure |
Etanercept
n=169 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Study 20050111 baseline (N = 161)
|
23.085 percent improvement
Standard Deviation 64.713
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Week 24 (N = 152)
|
13.268 percent improvement
Standard Deviation 74.987
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Week 48 (N = 144)
|
18.634 percent improvement
Standard Deviation 67.750
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Week 72 (N = 134)
|
23.383 percent improvement
Standard Deviation 73.210
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Week 96 (N = 128)
|
17.969 percent improvement
Standard Deviation 72.561
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Week 120 (N = 105)
|
17.778 percent improvement
Standard Deviation 65.709
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Week 144 (N = 104)
|
21.795 percent improvement
Standard Deviation 62.924
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Week 168 (N = 93)
|
20.430 percent improvement
Standard Deviation 73.849
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Week 192 (N = 81)
|
26.955 percent improvement
Standard Deviation 68.443
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Week 216 (N = 71)
|
31.455 percent improvement
Standard Deviation 59.598
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Week 240 (N = 65)
|
30.513 percent improvement
Standard Deviation 57.703
|
|
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Week 264 (N = 56)
|
37.500 percent improvement
Standard Deviation 64.842
|
SECONDARY outcome
Timeframe: Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264Population: Participants who received at least one dose of investigational product and who completed the joint pain assessment at Study 20030211 baseline, and with available data at each time point.
Participants were asked to indicate how much joint pain they had experienced in the last 7 days on a visual analog scale (VAS) from no pain on the left end of the line (score = 0) to severe pain on the right side of the line (score = 10). Improvement from baseline = (Baseline Value - Post-baseline Value).
Outcome measures
| Measure |
Etanercept
n=41 Participants
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Improvement From Study 20030211 Baseline in Joint Pain
Study 20050111 baseline (N = 31)
|
1.5 units on a scale
Standard Deviation 2.7
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 12 (N = 29)
|
2.3 units on a scale
Standard Deviation 2.5
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 24 (N = 22)
|
2.4 units on a scale
Standard Deviation 3.2
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 36 (N = 22)
|
1.5 units on a scale
Standard Deviation 3.2
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 48 (N = 24)
|
1.5 units on a scale
Standard Deviation 3.5
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 60 (N = 14)
|
1.3 units on a scale
Standard Deviation 3.2
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 72 (N = 16)
|
2.1 units on a scale
Standard Deviation 3.6
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 84 (N = 14)
|
2.9 units on a scale
Standard Deviation 3.0
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 96 (N = 16)
|
2.0 units on a scale
Standard Deviation 2.7
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 108 (N = 14)
|
2.4 units on a scale
Standard Deviation 3.4
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 120 (N = 12)
|
2.4 units on a scale
Standard Deviation 2.9
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 132 (N = 15)
|
1.9 units on a scale
Standard Deviation 3.7
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 144 (N = 12)
|
1.8 units on a scale
Standard Deviation 4.3
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 156 (N = 12)
|
2.5 units on a scale
Standard Deviation 3.8
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 168 (N = 10)
|
2.2 units on a scale
Standard Deviation 4.0
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 180 (N = 11)
|
2.7 units on a scale
Standard Deviation 3.3
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 192 (N = 11)
|
2.5 units on a scale
Standard Deviation 4.2
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 204 (N = 11)
|
2.8 units on a scale
Standard Deviation 3.6
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 216 (N = 9)
|
2.9 units on a scale
Standard Deviation 3.4
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 228 (N = 10)
|
2.8 units on a scale
Standard Deviation 3.6
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 240 (N = 9)
|
2.7 units on a scale
Standard Deviation 3.4
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 252 (N = 8)
|
3.9 units on a scale
Standard Deviation 3.7
|
|
Improvement From Study 20030211 Baseline in Joint Pain
Week 264 (N = 8)
|
3.9 units on a scale
Standard Deviation 3.3
|
Adverse Events
Etanercept
Serious adverse events
| Measure |
Etanercept
n=181 participants at risk
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Endocrine disorders
Thyroid cyst
|
0.55%
1/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.55%
1/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.55%
1/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infectious mononucleosis
|
0.55%
1/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.55%
1/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
0.55%
1/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Abortion induced
|
0.55%
1/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Etanercept
n=181 participants at risk
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
11/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
11/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
7.2%
13/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
9.4%
17/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
9.9%
18/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Ear infection
|
6.6%
12/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
7.7%
14/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis viral
|
7.7%
14/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
11.6%
21/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
26.0%
47/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngitis
|
8.3%
15/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngitis streptococcal
|
14.9%
27/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
13.3%
24/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
37.6%
68/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
6.6%
12/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.1%
11/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.1%
11/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.6%
12/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
14/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
13.3%
24/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
21.5%
39/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
22/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.4%
17/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.0%
20/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Acne
|
18.2%
33/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.1%
11/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
7.7%
14/181 • 264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER