Trial Outcomes & Findings for Etanercept (Enbrel®) in Psoriasis - Pediatrics (NCT NCT00078819)
NCT ID: NCT00078819
Last Updated: 2019-07-29
Results Overview
The percentage of participants who achieved 75% or greater improvement (decrease) from baseline in PASI score after 12 weeks of treatment. The PASI score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Participants who entered the escape arm or had missing data at week 12 were considered non-responders.
COMPLETED
PHASE3
211 participants
Baseline and week 12
2019-07-29
Participant Flow
This 48-week study was conducted at 42 sites in the United States and Canada. The first participant was enrolled on September 8, 2004, and the last participant on November 29, 2005.
On enrollment, participants underwent randomization at a 1:1 ratio by an interactive voice-response system.
Participant milestones
| Measure |
Placebo
Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
Participants (including those who escaped to etanercept) received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).
Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 (incomplete response) could discontinue the study or continue to receive open-label etanercept with a topical standard-of-care until week 48.
|
Etanercept
Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
Participants (including those who escaped to etanercept) received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).
Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 (incomplete response) could discontinue the study or continue to receive open-label etanercept with a topical standard-of-care until week 48.
|
Withdrawal/Re-treatment Period: Placebo
At week 36, participants with a PASI 75 response were re-randomized to receive placebo once a week for 12-weeks in the double-blind withdrawal period (weeks 37 to 48).
Participants who relapsed (defined as a loss of PASI 75 response) were to resume open-label treatment with 0.8 mg/kg etanercept once a week until week 48 (re-treatment period).
|
Withdrawal/Re-treatment Period: Etanercept
At week 36, participants with a PASI 75 response were re-randomized to receive 0.8 mg/kg etanercept once a week for 12-weeks in the double-blind, withdrawal period (weeks 37 to 48).
Participants who relapsed (defined as a loss of PASI 75 response) were to resume open-label treatment with 0.8 mg/kg etanercept once a week until week 48 (re-treatment period).
|
|---|---|---|---|---|
|
Double-blind Treatment Period: Week 1-12
STARTED
|
105
|
106
|
0
|
0
|
|
Double-blind Treatment Period: Week 1-12
Entered Escape
|
27
|
5
|
0
|
0
|
|
Double-blind Treatment Period: Week 1-12
COMPLETED
|
104
|
105
|
0
|
0
|
|
Double-blind Treatment Period: Week 1-12
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Open-label Treatment Period: Weeks 13-36
STARTED
|
103
|
105
|
0
|
0
|
|
Open-label Treatment Period: Weeks 13-36
COMPLETED
|
63
|
75
|
0
|
0
|
|
Open-label Treatment Period: Weeks 13-36
NOT COMPLETED
|
40
|
30
|
0
|
0
|
|
Withdrawal Period: Weeks 37-48
STARTED
|
0
|
0
|
69
|
69
|
|
Withdrawal Period: Weeks 37-48
Received Study Drug
|
0
|
0
|
69
|
68
|
|
Withdrawal Period: Weeks 37-48
COMPLETED
|
0
|
0
|
40
|
55
|
|
Withdrawal Period: Weeks 37-48
NOT COMPLETED
|
0
|
0
|
29
|
14
|
|
Re-treatment Period
STARTED
|
0
|
0
|
29
|
13
|
|
Re-treatment Period
Received Study Drug
|
0
|
0
|
30
|
12
|
|
Re-treatment Period
COMPLETED
|
0
|
0
|
29
|
13
|
|
Re-treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
Participants (including those who escaped to etanercept) received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).
Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 (incomplete response) could discontinue the study or continue to receive open-label etanercept with a topical standard-of-care until week 48.
|
Etanercept
Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
Participants (including those who escaped to etanercept) received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).
Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 (incomplete response) could discontinue the study or continue to receive open-label etanercept with a topical standard-of-care until week 48.
|
Withdrawal/Re-treatment Period: Placebo
At week 36, participants with a PASI 75 response were re-randomized to receive placebo once a week for 12-weeks in the double-blind withdrawal period (weeks 37 to 48).
Participants who relapsed (defined as a loss of PASI 75 response) were to resume open-label treatment with 0.8 mg/kg etanercept once a week until week 48 (re-treatment period).
|
Withdrawal/Re-treatment Period: Etanercept
At week 36, participants with a PASI 75 response were re-randomized to receive 0.8 mg/kg etanercept once a week for 12-weeks in the double-blind, withdrawal period (weeks 37 to 48).
Participants who relapsed (defined as a loss of PASI 75 response) were to resume open-label treatment with 0.8 mg/kg etanercept once a week until week 48 (re-treatment period).
|
|---|---|---|---|---|
|
Double-blind Treatment Period: Week 1-12
Adverse Event
|
0
|
1
|
0
|
0
|
|
Double-blind Treatment Period: Week 1-12
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Open-label Treatment Period: Weeks 13-36
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Open-label Treatment Period: Weeks 13-36
Adverse Event
|
3
|
2
|
0
|
0
|
|
Open-label Treatment Period: Weeks 13-36
Withdrawal by Subject
|
2
|
2
|
0
|
0
|
|
Open-label Treatment Period: Weeks 13-36
Incomplete Responders
|
34
|
25
|
0
|
0
|
|
Withdrawal Period: Weeks 37-48
Entered Retreatment
|
0
|
0
|
29
|
13
|
|
Withdrawal Period: Weeks 37-48
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Etanercept (Enbrel®) in Psoriasis - Pediatrics
Baseline characteristics by cohort
| Measure |
Placebo
n=105 Participants
Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12).
|
Etanercept
n=106 Participants
Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12).
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.00 years
n=5 Participants
|
14.00 years
n=7 Participants
|
13.00 years
n=5 Participants
|
|
Age, Customized
4 to 11 years
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Age, Customized
12 to 17 years
|
67 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
75 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Duration of Psoriasis
|
5.80 years
n=5 Participants
|
6.80 years
n=7 Participants
|
5.90 years
n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI)
|
16.40 units on a scale
n=5 Participants
|
16.70 units on a scale
n=7 Participants
|
16.40 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: The intent-to-treat population included all randomized participants.
The percentage of participants who achieved 75% or greater improvement (decrease) from baseline in PASI score after 12 weeks of treatment. The PASI score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Participants who entered the escape arm or had missing data at week 12 were considered non-responders.
Outcome measures
| Measure |
Placebo
n=105 Participants
Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Etanercept
n=106 Participants
Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Escape: Etanercept
Participants with a \> 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped to etanercept 0.8 mg/kg once a week up to week 12.
|
|---|---|---|---|
|
Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI 75) at Week 12
|
11.0 percentage of participants
|
57.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Intent-to-treat population
The percentage of participants who achieved 50% or greater improvement from baseline in PASI score after 12 weeks of treatment. PASI is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Participants who entered the escape arm or had missing data at week 12 were considered non-responders.
Outcome measures
| Measure |
Placebo
n=105 Participants
Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Etanercept
n=106 Participants
Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Escape: Etanercept
Participants with a \> 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped to etanercept 0.8 mg/kg once a week up to week 12.
|
|---|---|---|---|
|
Percentage of Participants Achieving a ≥ 50% Improvement in PASI Score (PASI 50) at Week 12
|
23 percentage of participants
|
75 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-treat population
The sPGA is a static measurement based on induration, erythema, and scaling. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling) 1. = almost clear (minimal plaque elevation, erythema or scaling) 2. = mild (mild plaque elevation or scaling, light red coloration) 3. = moderate (moderate plaque elevation, scaling, light red coloration) 4. = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration) 5. = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration). Participants who entered the escape arm or had missing data at week 12 were considered non-responders.
Outcome measures
| Measure |
Placebo
n=105 Participants
Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Etanercept
n=106 Participants
Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Escape: Etanercept
Participants with a \> 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped to etanercept 0.8 mg/kg once a week up to week 12.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) at Week 12
|
13 percentage of participants
|
53 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Intent-to-treat population with available CDLQI data at baseline
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. Participants who entered the escape arm or who had missing data at week 12 were considered to have 0% improvement from baseline.
Outcome measures
| Measure |
Placebo
n=102 Participants
Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Etanercept
n=100 Participants
Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Escape: Etanercept
Participants with a \> 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped to etanercept 0.8 mg/kg once a week up to week 12.
|
|---|---|---|---|
|
Percent Improvement From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 12
|
17.5 percent improvement
Standard Error 8.3
|
52.3 percent improvement
Standard Error 6.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Intent-to-treat population
The percentage of participants who achieved 90% or greater improvement from baseline in PASI score after 12 weeks of treatment. The PASI score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Participants who entered the escape arm or had missing data at week 12 were considered non-responders.
Outcome measures
| Measure |
Placebo
n=105 Participants
Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Etanercept
n=106 Participants
Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Escape: Etanercept
Participants with a \> 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped to etanercept 0.8 mg/kg once a week up to week 12.
|
|---|---|---|---|
|
Percentage of Participants Achieving a ≥ 90% Improvement in PASI Score (PASI 90) at Week 12
|
7 percentage of participants
|
27 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The safety population included all participants who received at least 1 dose of study drug.
The severity assessment for adverse events and infections was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 0 = no toxicity, Grade 1 = mild toxicity, Grade 2 = moderate toxicity, Grade 3 = severe toxicity, Grade 4 = life-threatening toxicity. Serious adverse events were any events that suggested a significant hazard or side effect, regardless of the investigator's or sponsor's opinion on the relationship to study medication. These included, but were not limited to, events at any dose that were fatal, life threatening, required in-patient hospitalization or prolonged hospitalization, were a persistent or significant disability/incapacity, or were a congenital abnormality/birth defect. Medical events that jeopardized a participant, required intervention to prevent one of the above outcomes, or resulted in urgent investigation could be considered serious.
Outcome measures
| Measure |
Placebo
n=105 Participants
Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Etanercept
n=106 Participants
Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Escape: Etanercept
n=32 Participants
Participants with a \> 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped to etanercept 0.8 mg/kg once a week up to week 12.
|
|---|---|---|---|
|
Number of Participants With Adverse Events During the Double-blind Treatment Period
Any adverse event
|
62 Participants
|
68 Participants
|
16 Participants
|
|
Number of Participants With Adverse Events During the Double-blind Treatment Period
Non-infectious adverse event
|
46 Participants
|
42 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events During the Double-blind Treatment Period
Infection
|
33 Participants
|
50 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events During the Double-blind Treatment Period
Serious non-infectious adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events During the Double-blind Treatment Period
Serious infection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events During the Double-blind Treatment Period
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events During the Double-blind Treatment Period
Grade 3 non-infectious adverse event
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events During the Double-blind Treatment Period
Grade 3 infection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events During the Double-blind Treatment Period
Non-infectious AE leading to withdrawal from Study
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events During the Double-blind Treatment Period
Infection leading to withdrawal from Study
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events During the Double-blind Treatment Period
Injection site reaction
|
5 Participants
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 (predose), week 12, week 24, and week 48Population: Participants assigned to etanercept at any time during the study, with available data. Week 12 excludes participants assigned to placebo who escaped to etanercept. Week 48 includes participants randomized to etanercept at week 36 and remaining on etanercept to week 48. Participants randomized to placebo and retreated with etanercept are excluded.
Serum concentrations for etanercept were measured by using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.627 ng/mL.
Outcome measures
| Measure |
Placebo
n=208 Participants
Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Etanercept
Participants randomized to receive 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
|
Escape: Etanercept
Participants with a \> 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped to etanercept 0.8 mg/kg once a week up to week 12.
|
|---|---|---|---|
|
Etanercept Serum Concentration
Day 1
|
1.50 ng/mL
Standard Deviation 3.13
|
—
|
—
|
|
Etanercept Serum Concentration
Week 12
|
1614 ng/mL
Standard Deviation 828
|
—
|
—
|
|
Etanercept Serum Concentration
Week 24
|
2104 ng/mL
Standard Deviation 1255
|
—
|
—
|
|
Etanercept Serum Concentration
Week 48
|
1650 ng/mL
Standard Deviation 1126
|
—
|
—
|
Adverse Events
Double-blind Period: Placebo
Double-blind Period: Etanercept 0.8 mg/kg QW
Double-blind Period: Escape to Etanercept 0.8 mg/kg QW
Open-label Period: Etanercept 0.8 mg/kg QW
Open-label Period Incomplete Response: Etanercept 0.8 mg/kg QW
Withdrawal Period: Placebo
Withdrawal Period: Etanercept 0.8 mg/kg QW
Re-treatment Period: Placebo/Etanercept 0.8 mg/kg QW
Re-treatment Period: Etanercept / Etanercept 0.8 mg/kg QW
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Double-blind Period: Placebo
n=105 participants at risk
Participants received placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12).
|
Double-blind Period: Etanercept 0.8 mg/kg QW
n=106 participants at risk
Participants received 0.8 mg/kg etanercept administered by subcutaneous injection once a week (QW) during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12).
|
Double-blind Period: Escape to Etanercept 0.8 mg/kg QW
n=32 participants at risk
Participants with a \> 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped to etanercept 0.8 mg/kg once a week up to week 12.
|
Open-label Period: Etanercept 0.8 mg/kg QW
n=208 participants at risk
Participants received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).
|
Open-label Period Incomplete Response: Etanercept 0.8 mg/kg QW
n=59 participants at risk
Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 continued to receive open-label etanercept 0.8 mg/kg QW plus optional topical standard-of-care therapy (low-to-moderate-potency topical corticosteroids) until week 48.
|
Withdrawal Period: Placebo
n=69 participants at risk
At week 36, participants with a PASI 75 response were re-randomized to receive placebo once a week for 12 weeks in the double-blind, withdrawal period (weeks 37 to 48) or until relapse (loss of PASI 75 response).
|
Withdrawal Period: Etanercept 0.8 mg/kg QW
n=68 participants at risk
At week 36, participants with a PASI 75 response were re-randomized to receive 0.8 mg/kg etanercept once a week for 12-weeks in the double-blind, withdrawal period (weeks 37 to 48) or until relapse (loss of PASI 75 response).
|
Re-treatment Period: Placebo/Etanercept 0.8 mg/kg QW
n=30 participants at risk
Participants randomized to placebo at week 36 who relapsed (loss of PASI 75 response) resumed open-label treatment with 0.8 mg/kg etanercept once a week until week 48.
|
Re-treatment Period: Etanercept / Etanercept 0.8 mg/kg QW
n=12 participants at risk
Participants randomized to etanercept at week 36 who relapsed (loss of PASI 75 response) resumed open-label treatment with 0.8 mg/kg etanercept once a week until week 48.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
6/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.9%
2/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
11/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
2/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
4/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.94%
1/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
9/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.8%
4/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
3/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
13/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
3/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
2/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
4/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.2%
15/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.2%
6/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection Site Bruising
|
3.8%
4/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.94%
1/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.8%
12/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
3/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection Site Pain
|
0.00%
0/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
6/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
3/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
7/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
3/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.95%
1/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.8%
12/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
1/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Seasonal Allergy
|
0.95%
1/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.94%
1/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
4/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
1/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Body Tinea
|
0.00%
0/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
3/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Conjunctivitis Viral
|
0.00%
0/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.48%
1/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Ear Infection
|
0.95%
1/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
9/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
2/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
6/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
3/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.7%
6/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
13/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.8%
4/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
1/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis Viral
|
2.9%
3/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
13/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.5%
5/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
1.9%
2/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.5%
8/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
23/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
2/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
1/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
9/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.5%
8/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
18.8%
39/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.3%
12/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.3%
7/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Otitis Media
|
1.9%
2/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
10/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.5%
5/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
1/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngitis
|
3.8%
4/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
13/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.5%
5/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.95%
1/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.2%
17/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.2%
6/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
0.95%
1/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.94%
1/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.8%
12/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
3/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
2/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Skin Infection
|
0.95%
1/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.94%
1/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
8/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.8%
4/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 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
|
11.4%
12/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.0%
18/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
4/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.8%
64/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
42.4%
25/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
7/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
3/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
3/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
5/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
10/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.8%
4/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 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
|
0.00%
0/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
13/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
3/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
0.95%
1/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
5/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
8/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
3/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
12.4%
13/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.2%
14/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.2%
42/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.3%
12/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.8%
6/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
2/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
4/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.1%
19/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.8%
4/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.2%
5/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 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
|
2.9%
3/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.2%
17/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
3/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
2/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
5.7%
6/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.94%
1/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.6%
20/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.3%
9/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
3/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.9%
2/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
9/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.5%
5/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
10/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.8%
4/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Guttate Psoriasis
|
0.95%
1/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.94%
1/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
4/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
3/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/105 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.94%
1/106 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
5/208 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
3/59 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/69 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
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