Trial Outcomes & Findings for Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA (NCT NCT00858780)
NCT ID: NCT00858780
Last Updated: 2013-09-11
Results Overview
A participant was considered as non-failure if the calculated DAS28 \<=3.2 at all visits or if the calculated DAS28 \>3.2, the increase of calculated DAS28 from randomization (Week 0): was \<0.6 at all visit or was \>=0.6 but \<1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
91 participants
Primary outcome timeframe
Week 48
Results posted on
2013-09-11
Participant Flow
Participant milestones
| Measure |
Etanercept 50 mg - Period 1
Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (\<=) 3.2 in Period 1 were randomized in Period 2.
|
Etanercept 50 mg - Period 2
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 50 mg - Period 3
Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
|
|---|---|---|---|---|---|
|
Open-Label (OL) Run-In(Week-8 to Week 0)
STARTED
|
91
|
0
|
0
|
0
|
0
|
|
Open-Label (OL) Run-In(Week-8 to Week 0)
COMPLETED
|
73
|
0
|
0
|
0
|
0
|
|
Open-Label (OL) Run-In(Week-8 to Week 0)
NOT COMPLETED
|
18
|
0
|
0
|
0
|
0
|
|
Double-Blind (Week 0 to Failure/Week 48)
STARTED
|
0
|
23
|
27
|
23
|
0
|
|
Double-Blind (Week 0 to Failure/Week 48)
COMPLETED
|
0
|
21
|
25
|
22
|
0
|
|
Double-Blind (Week 0 to Failure/Week 48)
NOT COMPLETED
|
0
|
2
|
2
|
1
|
0
|
|
OL Re-Treatment (Failure to Week 48)
STARTED
|
0
|
0
|
0
|
0
|
43
|
|
OL Re-Treatment (Failure to Week 48)
COMPLETED
|
0
|
0
|
0
|
0
|
41
|
|
OL Re-Treatment (Failure to Week 48)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Etanercept 50 mg - Period 1
Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (\<=) 3.2 in Period 1 were randomized in Period 2.
|
Etanercept 50 mg - Period 2
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 50 mg - Period 3
Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
|
|---|---|---|---|---|---|
|
Open-Label (OL) Run-In(Week-8 to Week 0)
Did not enter double-blind period
|
18
|
0
|
0
|
0
|
0
|
|
Double-Blind (Week 0 to Failure/Week 48)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Double-Blind (Week 0 to Failure/Week 48)
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
0
|
|
Double-Blind (Week 0 to Failure/Week 48)
Other
|
0
|
1
|
0
|
0
|
0
|
|
OL Re-Treatment (Failure to Week 48)
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
OL Re-Treatment (Failure to Week 48)
Other
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=91 Participants
Includes all participants who were enrolled in this study.
|
|---|---|
|
Age Continuous
|
56.14 years
STANDARD_DEVIATION 11.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Modified intent-to-treat (m-ITT) analysis set included all randomized participants who received at least 1 dose of study medication after randomization and had at least 1 available evaluation after the first administration of study medication after randomization.
A participant was considered as non-failure if the calculated DAS28 \<=3.2 at all visits or if the calculated DAS28 \>3.2, the increase of calculated DAS28 from randomization (Week 0): was \<0.6 at all visit or was \>=0.6 but \<1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Percentage of Participant Who Were Non-Failures
|
52.2 percentage of participants
|
44.4 percentage of participants
|
13.0 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization (Week 0) up to date of failure, withdrawal due to disease progression or last evaluation visit (Week 48)Population: m-ITT analysis set.
TTF (in weeks): (date of failure minus date of randomization) divided by 7. Date of failure was ordinary visit date or extra visit date in case of failure (extra visit was within 2 weeks from the date a participant experienced significant disease progression between visits and wanted to withdraw from Period 2), or date of withdrawal due to disease progression. Participants who did not have a treatment failure were censored at their last evaluation visit. Participants who withdrew from the study prematurely and did not have a treatment failure were censored on the date of their withdrawal.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Time to Treatment Failure (TTF)
|
48.0 weeks
Interval 18.1 to
Upper limit of confidence interval was not evaluable since there were only 50% treatment failures and there was lack of information on the later failure times.
|
36.1 weeks
Interval 15.6 to
Upper limit of confidence interval was not evaluable since there were only 50% treatment failures and there was lack of information on the later failure times.
|
6.1 weeks
Interval 4.0 to 8.4
|
SECONDARY outcome
Timeframe: Baseline (Week -8), Week -4, Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48Population: m-ITT analysis set. Here, 'n' signifies participants evaluable for each time-point for each treatment arm, respectively.
Participants who had DAS28 less than or equal to (\<=) 3.2 were considered in remission or LDA state.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Percentage of Participants With Remission or Low Disease Activity (LDA)
Baseline (n= 19, 23, 19)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Remission or Low Disease Activity (LDA)
Week 30 (n= 14, 15, 3)
|
92.9 percentage of participants
|
100 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Remission or Low Disease Activity (LDA)
Week -4 (n= 23, 26, 23)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Remission or Low Disease Activity (LDA)
Randomization (n= 22, 27, 23)
|
100 percentage of participants
|
96.3 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Remission or Low Disease Activity (LDA)
Week 6 (n= 21, 26, 15)
|
90.5 percentage of participants
|
80.8 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants With Remission or Low Disease Activity (LDA)
Week 12 (n= 18, 21, 6)
|
94.4 percentage of participants
|
85.7 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With Remission or Low Disease Activity (LDA)
Week 18 (n= 16, 19, 3)
|
87.5 percentage of participants
|
89.5 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Remission or Low Disease Activity (LDA)
Week 24 (n= 14, 16, 3)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Remission or Low Disease Activity (LDA)
Week 36 (n= 13, 14, 2)
|
100 percentage of participants
|
85.7 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Remission or Low Disease Activity (LDA)
Week 42 (n= 12, 12, 2)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Remission or Low Disease Activity (LDA)
Week 48 (n= 12, 12, 2)
|
83.3 percentage of participants
|
91.7 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization (Week 0) up to Week 48Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
Participants who had DAS28 \<=3.2 were considered in remission or LDA state. Percentage of visits during which a participant was in remission or LDA state was calculated as number of visits in which participant was in remission or LDA divided by total number of visits multiplied by 100.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=22 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=15 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State
|
82.7 percentage of visits
Standard Deviation 31.1
|
74.8 percentage of visits
Standard Deviation 38.0
|
55.3 percentage of visits
Standard Deviation 48.5
|
SECONDARY outcome
Timeframe: Randomization (Week 0)Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 implied low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity and less than (\<) 2.6=remission.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=22 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization
|
1.86 units on a scale
Standard Deviation 0.62
|
1.93 units on a scale
Standard Deviation 0.85
|
1.93 units on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
DAS28 calculated from SJC and PJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity and \<2.6=remission.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=21 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=26 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=15 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 48
|
0.46 units on a scale
Standard Error 0.27
|
0.92 units on a scale
Standard Error 0.29
|
1.17 units on a scale
Standard Error 0.80
|
|
Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 6
|
0.11 units on a scale
Standard Error 0.24
|
0.47 units on a scale
Standard Error 0.25
|
0.85 units on a scale
Standard Error 0.36
|
|
Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 12
|
0.38 units on a scale
Standard Error 0.25
|
0.32 units on a scale
Standard Error 0.26
|
1.33 units on a scale
Standard Error 0.53
|
|
Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 18
|
0.41 units on a scale
Standard Error 0.25
|
0.64 units on a scale
Standard Error 0.27
|
1.14 units on a scale
Standard Error 0.69
|
|
Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 24
|
-0.00 units on a scale
Standard Error 0.26
|
0.66 units on a scale
Standard Error 0.28
|
1.02 units on a scale
Standard Error 0.69
|
|
Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 30
|
0.24 units on a scale
Standard Error 0.26
|
0.74 units on a scale
Standard Error 0.28
|
1.12 units on a scale
Standard Error 0.69
|
|
Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 36
|
0.18 units on a scale
Standard Error 0.26
|
1.00 units on a scale
Standard Error 0.28
|
0.45 units on a scale
Standard Error 0.80
|
|
Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 42
|
0.14 units on a scale
Standard Error 0.27
|
0.45 units on a scale
Standard Error 0.29
|
1.02 units on a scale
Standard Error 0.80
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48Population: m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from randomization indicates an improvement.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Randomization (n=23,27,23)
|
0.0 tender joints
Interval 0.0 to 2.0
|
0.0 tender joints
Interval 0.0 to 2.0
|
0.0 tender joints
Interval 0.0 to 3.0
|
|
Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 6 (n= 22, 26, 15)
|
0.0 tender joints
Interval -2.0 to 6.0
|
0.0 tender joints
Interval -2.0 to 9.0
|
1.0 tender joints
Interval 0.0 to 9.0
|
|
Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 12 (n= 18, 21, 6)
|
0.0 tender joints
Interval 0.0 to 6.0
|
0.0 tender joints
Interval -2.0 to 2.0
|
0.5 tender joints
Interval 0.0 to 24.0
|
|
Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 18 (n= 16, 19, 3)
|
0.0 tender joints
Interval -1.0 to 2.0
|
0.0 tender joints
Interval -2.0 to 6.0
|
0.0 tender joints
Interval 0.0 to 0.0
|
|
Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 24 (n= 14, 16, 3)
|
0.0 tender joints
Interval 0.0 to 0.0
|
0.0 tender joints
Interval -1.0 to 2.0
|
0.0 tender joints
Interval 0.0 to 1.0
|
|
Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 30 (n= 14, 15, 3)
|
0.0 tender joints
Interval -1.0 to 7.0
|
0.0 tender joints
Interval -2.0 to 7.0
|
0.0 tender joints
Interval -1.0 to 4.0
|
|
Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 36 (n= 13, 14, 2)
|
0.0 tender joints
Interval 0.0 to 1.0
|
0.0 tender joints
Interval -2.0 to 4.0
|
-0.5 tender joints
Interval -1.0 to 0.0
|
|
Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 42 (n= 12, 12, 2)
|
0.0 tender joints
Interval -2.0 to 1.0
|
0.0 tender joints
Interval -2.0 to 0.0
|
-0.5 tender joints
Interval -1.0 to 0.0
|
|
Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 48 (n= 12, 12, 2)
|
0.0 tender joints
Interval -2.0 to 1.0
|
0.0 tender joints
Interval -1.0 to 2.0
|
0.5 tender joints
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48Population: m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from randomization indicates an improvement.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Randomization (n=23,27,23)
|
0.0 swollen joints
Interval 0.0 to 3.0
|
0.0 swollen joints
Interval 0.0 to 3.0
|
0.0 swollen joints
Interval 0.0 to 1.0
|
|
Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 6 (n= 22, 26, 15)
|
0.0 swollen joints
Interval -1.0 to 5.0
|
0.0 swollen joints
Interval -1.0 to 11.0
|
0.0 swollen joints
Interval 0.0 to 6.0
|
|
Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 12 (n= 18, 21, 6)
|
0.0 swollen joints
Interval -1.0 to 4.0
|
0.0 swollen joints
Interval -1.0 to 3.0
|
1.0 swollen joints
Interval 0.0 to 6.0
|
|
Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 18 (n= 16, 19, 3)
|
0.0 swollen joints
Interval -1.0 to 2.0
|
0.0 swollen joints
Interval -3.0 to 8.0
|
0.0 swollen joints
Interval 0.0 to 2.0
|
|
Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 24 (n= 14, 16, 3)
|
0.0 swollen joints
Interval -3.0 to 1.0
|
0.0 swollen joints
Interval -1.0 to 1.0
|
0.0 swollen joints
Interval 0.0 to 1.0
|
|
Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 30 (n= 14, 15, 3)
|
0.0 swollen joints
Interval -2.0 to 5.0
|
0.0 swollen joints
Interval -3.0 to 3.0
|
0.0 swollen joints
Interval 0.0 to 4.0
|
|
Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 36 (n= 13, 14, 2)
|
0.0 swollen joints
Interval -2.0 to 1.0
|
0.0 swollen joints
Interval -1.0 to 3.0
|
0.0 swollen joints
Interval 0.0 to 0.0
|
|
Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 42 (n= 12, 12, 2)
|
0.0 swollen joints
Interval -1.0 to 3.0
|
0.0 swollen joints
Interval -1.0 to 1.0
|
0.0 swollen joints
Interval 0.0 to 0.0
|
|
Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 48 (n= 12, 12, 2)
|
0.0 swollen joints
Interval -2.0 to 1.0
|
0.0 swollen joints
Interval -2.0 to 0.0
|
0.5 swollen joints
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
PGA of disease activity was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 mm = extreme disease activity.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=22 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Randomization (n=23,27,22)
|
4.00 mm
Interval 0.0 to 13.0
|
3.00 mm
Interval 0.0 to 30.5
|
2.25 mm
Interval 0.0 to 19.0
|
|
Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 6 (n= 22, 26, 14)
|
1.50 mm
Interval -8.0 to 20.5
|
0.25 mm
Interval -7.0 to 58.0
|
4.00 mm
Interval -9.0 to 50.0
|
|
Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 12 (n= 18, 21, 6)
|
1.00 mm
Interval -6.0 to 17.0
|
0.50 mm
Interval -7.0 to 14.0
|
6.75 mm
Interval -4.5 to 42.0
|
|
Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 18 (n= 16, 19, 3)
|
2.50 mm
Interval -11.0 to 18.0
|
4.00 mm
Interval -7.0 to 32.0
|
10.00 mm
Interval -4.0 to 16.0
|
|
Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 24 (n= 14, 15, 3)
|
1.00 mm
Interval -9.0 to 8.0
|
2.00 mm
Interval -7.0 to 23.0
|
8.00 mm
Interval -5.0 to 14.0
|
|
Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 30 (n= 14, 15, 3)
|
1.00 mm
Interval -3.0 to 55.0
|
0.00 mm
Interval -7.0 to 35.0
|
5.00 mm
Interval -5.0 to 18.0
|
|
Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 36 (n= 13, 14, 2)
|
0.00 mm
Interval -4.0 to 9.0
|
0.00 mm
Interval -7.5 to 36.0
|
-6.50 mm
Interval -16.0 to 3.0
|
|
Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 42 (n= 12, 12, 2)
|
0.25 mm
Interval -6.0 to 26.0
|
-1.00 mm
Interval -9.0 to 3.0
|
-3.00 mm
Interval -6.0 to 0.0
|
|
Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 48 (n= 12, 12, 2)
|
0.25 mm
Interval -3.0 to 16.0
|
-1.75 mm
Interval -8.5 to 4.0
|
-1.50 mm
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48Population: m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
Participants assessed the overall activity of their rheumatoid arthritis (RA) on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extreme disease activity.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Randomization (n=23,27,23)
|
8.00 mm
Interval 0.0 to 72.0
|
12.00 mm
Interval 0.0 to 52.5
|
13.00 mm
Interval 0.0 to 41.0
|
|
Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 6 (n= 22, 26, 15)
|
2.50 mm
Interval -20.0 to 42.5
|
0.25 mm
Interval -25.5 to 57.0
|
10.00 mm
Interval -33.0 to 57.0
|
|
Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 12 (n= 18, 21, 6)
|
-0.25 mm
Interval -18.5 to 16.0
|
0.00 mm
Interval -15.0 to 28.0
|
18.00 mm
Interval -28.0 to 51.0
|
|
Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 18 (n= 16, 19, 3)
|
0.00 mm
Interval -18.5 to 62.0
|
-0.50 mm
Interval -9.5 to 26.0
|
20.00 mm
Interval -27.0 to 21.0
|
|
Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 24 (n= 14, 16, 3)
|
0.00 mm
Interval -22.5 to 10.0
|
0.50 mm
Interval -18.5 to 27.0
|
4.00 mm
Interval -22.0 to 11.0
|
|
Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 30 (n= 14, 15, 3)
|
-1.00 mm
Interval -22.5 to 47.0
|
0.50 mm
Interval -29.5 to 9.5
|
-5.50 mm
Interval -27.0 to 38.5
|
|
Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 36 (n= 13, 14, 2)
|
0.00 mm
Interval -24.5 to 13.0
|
0.50 mm
Interval -9.5 to 16.5
|
-24.00 mm
Interval -38.0 to -10.0
|
|
Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 42 (n= 12, 12, 2)
|
-0.50 mm
Interval -21.5 to 29.0
|
-0.25 mm
Interval -28.5 to 27.0
|
-7.50 mm
Interval -27.0 to 12.0
|
|
Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 48 (n= 12, 12, 2)
|
1.50 mm
Interval -24.0 to 22.0
|
-1.00 mm
Interval -34.5 to 12.0
|
-7.00 mm
Interval -26.0 to 12.0
|
SECONDARY outcome
Timeframe: Randomization (Week 0)Population: m-ITT analysis set.
Participants answered "in general how would you rate your health over the last 2-3 weeks?" Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Participant General Health Visual Analog Scale (VAS) at Randomization
|
14.43 mm
Standard Deviation 12.87
|
15.11 mm
Standard Deviation 13.15
|
18.52 mm
Standard Deviation 15.35
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48Population: m-ITT analysis set.
Participants answered "in general how would you rate your health over the last 2-3 weeks?" Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 6
|
8.21 mm
Standard Error 4.74
|
8.67 mm
Standard Error 4.70
|
8.37 mm
Standard Error 6.59
|
|
Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 12
|
4.09 mm
Standard Error 5.03
|
10.21 mm
Standard Error 4.86
|
18.47 mm
Standard Error 10.06
|
|
Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 18
|
8.14 mm
Standard Error 5.16
|
12.29 mm
Standard Error 4.93
|
11.30 mm
Standard Error 13.70
|
|
Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 24
|
9.86 mm
Standard Error 5.42
|
9.70 mm
Standard Error 5.09
|
-0.15 mm
Standard Error 13.71
|
|
Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 30
|
9.09 mm
Standard Error 5.38
|
13.84 mm
Standard Error 5.11
|
6.88 mm
Standard Error 13.71
|
|
Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 36
|
9.18 mm
Standard Error 5.49
|
17.49 mm
Standard Error 5.16
|
-3.20 mm
Standard Error 16.31
|
|
Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 42
|
8.15 mm
Standard Error 5.62
|
14.01 mm
Standard Error 5.26
|
29.87 mm
Standard Error 16.32
|
|
Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 48
|
12.04 mm
Standard Error 5.63
|
16.09 mm
Standard Error 5.26
|
6.36 mm
Standard Error 16.33
|
SECONDARY outcome
Timeframe: Randomization (Week 0)Population: m-ITT analysis set.
Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Participant Pain Visual Analog Scale (VAS) at Randomization
|
15.59 mm
Standard Deviation 18.16
|
12.96 mm
Standard Deviation 10.92
|
13.37 mm
Standard Deviation 10.05
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48Population: m-ITT analysis set.
Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 6
|
1.90 mm
Standard Error 3.32
|
5.67 mm
Standard Error 3.69
|
22.70 mm
Standard Error 6.39
|
|
Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 12
|
-3.05 mm
Standard Error 3.56
|
8.05 mm
Standard Error 3.84
|
34.27 mm
Standard Error 9.43
|
|
Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 18
|
2.21 mm
Standard Error 3.61
|
12.21 mm
Standard Error 3.90
|
12.91 mm
Standard Error 12.40
|
|
Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 24
|
-1.18 mm
Standard Error 3.88
|
7.46 mm
Standard Error 4.06
|
11.32 mm
Standard Error 12.41
|
|
Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 30
|
3.20 mm
Standard Error 3.81
|
7.13 mm
Standard Error 4.08
|
15.97 mm
Standard Error 12.41
|
|
Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 36
|
2.05 mm
Standard Error 3.90
|
13.00 mm
Standard Error 4.15
|
1.46 mm
Standard Error 14.49
|
|
Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 42
|
1.06 mm
Standard Error 4.02
|
12.84 mm
Standard Error 4.26
|
7.13 mm
Standard Error 14.49
|
|
Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 48
|
1.32 mm
Standard Error 4.06
|
9.13 mm
Standard Error 4.28
|
6.47 mm
Standard Error 14.50
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. The duration of morning stiffness was determined by asking the following questions: 1) Over the last 2 days, when did you wake in the morning? 2) Over the last 2 days, when were you able to resume your normal activities without stiffness? Increase in stiffness duration from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=26 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48
Randomization (n=23,26,23)
|
10.0 minutes
Interval 0.0 to 240.0
|
0.5 minutes
Interval 0.0 to 240.0
|
5.0 minutes
Interval 0.0 to 120.0
|
|
Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 6 (n= 22, 25, 15)
|
0.0 minutes
Interval -60.0 to 50.0
|
0.0 minutes
Interval -30.0 to 120.0
|
0.0 minutes
Interval -5.0 to 1440.0
|
|
Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 12 (n= 18, 20, 5)
|
0.0 minutes
Interval -15.0 to 10.0
|
0.0 minutes
Interval -30.0 to 1410.0
|
1.0 minutes
Interval 0.0 to 60.0
|
|
Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 18 (n= 16, 19, 3)
|
0.0 minutes
Interval 0.0 to 1410.0
|
0.0 minutes
Interval -30.0 to 1410.0
|
0.0 minutes
Interval -5.0 to 15.0
|
|
Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 24 (n= 14, 16, 3)
|
0.0 minutes
Interval -30.0 to 5.0
|
0.0 minutes
Interval -60.0 to 90.0
|
0.0 minutes
Interval -5.0 to 0.0
|
|
Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 30 (n= 14, 15, 3)
|
0.0 minutes
Interval -15.0 to 330.0
|
0.0 minutes
Interval -110.0 to 60.0
|
-5.0 minutes
Interval -15.0 to 0.0
|
|
Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 36 (n= 13, 14, 2)
|
0.0 minutes
Interval -15.0 to 0.0
|
0.0 minutes
Interval -120.0 to 60.0
|
-2.5 minutes
Interval -5.0 to 0.0
|
|
Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 42 (n= 12, 11, 2)
|
0.0 minutes
Interval -10.0 to 5.0
|
0.0 minutes
Interval -120.0 to 60.0
|
-2.5 minutes
Interval -5.0 to 0.0
|
|
Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 48 (n= 12, 11, 2)
|
0.0 minutes
Interval -10.0 to 15.0
|
0.0 minutes
Interval -30.0 to 60.0
|
-5.0 minutes
Interval -10.0 to 0.0
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A higher rate is consistent with inflammation.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=22 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Randomization (n=22,27,23)
|
10.00 mm/hour
Interval 2.0 to 30.0
|
8.00 mm/hour
Interval 1.0 to 22.0
|
8.00 mm/hour
Interval 1.0 to 20.0
|
|
Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 6 (n= 21, 26, 15)
|
0.00 mm/hour
Interval -8.0 to 10.0
|
0.00 mm/hour
Interval -14.0 to 26.0
|
2.00 mm/hour
Interval -6.0 to 26.0
|
|
Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 12 (n= 17, 21, 6)
|
0.00 mm/hour
Interval -7.0 to 15.0
|
0.00 mm/hour
Interval -8.0 to 11.0
|
0.50 mm/hour
Interval -8.0 to 7.0
|
|
Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 18 (n= 15, 19, 3)
|
1.00 mm/hour
Interval -6.0 to 25.0
|
1.00 mm/hour
Interval -7.0 to 32.0
|
2.00 mm/hour
Interval -6.0 to 10.0
|
|
Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 24 (n= 14, 16, 3)
|
-1.00 mm/hour
Interval -14.0 to 10.0
|
0.00 mm/hour
Interval -5.0 to 21.0
|
1.00 mm/hour
Interval -6.0 to 4.0
|
|
Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 30 (n= 14, 15, 3)
|
-1.50 mm/hour
Interval -15.0 to 23.0
|
0.00 mm/hour
Interval -4.0 to 27.0
|
1.00 mm/hour
Interval -4.0 to 5.0
|
|
Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 36 (n= 13, 14, 2)
|
0.00 mm/hour
Interval -7.0 to 4.0
|
1.50 mm/hour
Interval -5.0 to 45.0
|
-2.50 mm/hour
Interval -6.0 to 1.0
|
|
Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 42 (n= 12, 12, 2)
|
-1.50 mm/hour
Interval -14.0 to 1.0
|
0.00 mm/hour
Interval -7.0 to 11.0
|
-0.50 mm/hour
Interval -4.0 to 3.0
|
|
Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 48 (n= 12, 12, 2)
|
2.00 mm/hour
Interval -4.0 to 36.0
|
1.00 mm/hour
Interval -3.0 to 43.0
|
-2.50 mm/hour
Interval -6.0 to 1.0
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48Population: m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is \<10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48
Randomization (n=23,27,23)
|
2.00 mg/L
Interval 0.6 to 12.0
|
3.00 mg/L
Interval 0.2 to 66.0
|
1.60 mg/L
Interval 0.6 to 8.0
|
|
Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 6 (n= 22, 26, 15)
|
0.00 mg/L
Interval -9.0 to 59.0
|
0.00 mg/L
Interval -33.2 to 31.7
|
0.33 mg/L
Interval -3.0 to 17.9
|
|
Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 12 (n= 18, 20, 6)
|
0.00 mg/L
Interval -10.0 to 44.0
|
0.00 mg/L
Interval -63.4 to 12.0
|
0.00 mg/L
Interval -3.0 to 4.1
|
|
Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 18 (n= 16, 19, 3)
|
0.00 mg/L
Interval -4.0 to 12.0
|
0.00 mg/L
Interval -4.0 to 139.0
|
2.74 mg/L
Interval 1.0 to 26.4
|
|
Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 24 (n= 14, 16, 3)
|
0.00 mg/L
Interval -4.0 to 1.1
|
0.00 mg/L
Interval -3.1 to 2.5
|
1.00 mg/L
Interval 0.2 to 4.3
|
|
Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 30 (n= 14, 15, 3)
|
0.00 mg/L
Interval -3.0 to 5.1
|
0.00 mg/L
Interval -3.0 to 9.0
|
1.20 mg/L
Interval 1.0 to 73.6
|
|
Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 36 (n= 13, 14, 2)
|
0.00 mg/L
Interval -2.0 to 2.9
|
0.00 mg/L
Interval -5.0 to 29.8
|
0.94 mg/L
Interval 0.0 to 1.9
|
|
Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 42 (n= 12, 12, 2)
|
0.00 mg/L
Interval -3.0 to 1.0
|
0.00 mg/L
Interval -3.1 to 1.0
|
3.49 mg/L
Interval 3.0 to 4.0
|
|
Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48
Change at Week 48 (n= 12, 12, 2)
|
0.00 mg/L
Interval -4.0 to 45.0
|
0.00 mg/L
Interval -5.0 to 6.0
|
-1.42 mg/L
Interval -3.8 to 1.0
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 48Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at randomization. An increase in mTSS from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=19 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=22 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=17 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48
Randomization (n=19, 22, 17)
|
19.50 units on a scale
Interval 0.5 to 176.0
|
54.25 units on a scale
Interval 3.5 to 219.0
|
23.00 units on a scale
Interval 4.0 to 89.5
|
|
Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48
Change at Week 48 (n= 9, 9, 1)
|
0.00 units on a scale
Interval -1.0 to 0.0
|
0.00 units on a scale
Interval -2.0 to 0.5
|
-1.00 units on a scale
Interval -1.0 to -1.0
|
SECONDARY outcome
Timeframe: Randomization (Week 0)Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
MRI of hand/wrist of dominant hand scored for signs of synovitis (S-score), bone edema(O-score), bone erosions (E-score) as per outcome measures in RA clinical trials (OMERACT). S-score:0(normal)-3(severe) for distal radioulnar,radiocarpal,intercarpal-carpometacarpal,second-fifth metacarpophalangeal joints, total score(TS)0-21, higher score(HS)=severe synovitis. O-score:0(no volume increment)-3(100% volume increment) in 23 hand/wrist joints, TS 0-69, HS=more edema. E-score:0(no volume occupied by erosion)-10(100% volume occupied by erosion) in 23 hand/wrist joints, TS 0-230, HS=more erosion.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=18 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=21 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=15 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) Findings at Randomization
S-Score
|
4.19 units on a scale
Standard Deviation 3.13
|
4.90 units on a scale
Standard Deviation 3.26
|
4.37 units on a scale
Standard Deviation 4.43
|
|
Magnetic Resonance Imaging (MRI) Findings at Randomization
O-Score
|
1.50 units on a scale
Standard Deviation 1.34
|
3.14 units on a scale
Standard Deviation 3.95
|
3.63 units on a scale
Standard Deviation 3.36
|
|
Magnetic Resonance Imaging (MRI) Findings at Randomization
E-Score
|
12.53 units on a scale
Standard Deviation 18.47
|
25.10 units on a scale
Standard Deviation 28.23
|
12.60 units on a scale
Standard Deviation 10.80
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 12Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. S-score: 0 (normal) to 3 (severe) for each of distal radioulnar, radiocarpal, intercarpal-carpometacarpal, second to fifth metacarpophalangeal joints; total score 0 to 21, higher score=severe synovitis.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=15 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=14 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=3 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12
|
-0.16 units on a scale
Standard Error 0.56
|
1.36 units on a scale
Standard Error 0.68
|
-0.29 units on a scale
Standard Error 1.15
|
SECONDARY outcome
Timeframe: Randomization (Week 0), Week 12Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. O-score: 0 (no volume increment) to 3 (100% volume increment) in 23 hand/wrist joints; total score 0 to 69, higher scores=more edema. E-score: 0 (no volume occupied by erosion) to 10 (100% volume occupied by erosion) in 23 hand/wrist joints; total score 0 to 230, higher scores=more erosion.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=15 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=14 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=3 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12
Change at Week 12: O-Score
|
0.00 units on a scale
Interval -2.0 to 0.0
|
0.00 units on a scale
Interval -0.5 to 2.0
|
-3.00 units on a scale
Interval -4.0 to 0.5
|
|
Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12
Change at Week 12: E-Score
|
0.00 units on a scale
Interval -1.0 to 0.5
|
0.00 units on a scale
Interval -0.5 to 4.0
|
0.00 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Randomization (Week 0) up to Week 48Population: m-ITT analysis set.
Percentage of participants who were treatment failure over 48 weeks as per potentially predictor variables (at randomization) are reported: number of swollen joints/tender joints, DAS28, PGA, PtGA, participant general health VAS, participant pain VAS, clinical disease activity index (CDAI), simplified disease activity index (SDAI), ESR (mm/hour), plasma CRP (mg/L), sensitive serum CRP (mg/L), anti- cyclic citrullinated peptide (anti CCP, units/mL), cartilage oligomeric matrix protein (COMP, units/liter), S-score, O-score, E-score, Joint space narrowing score, erosion score, and mTSS.
Outcome measures
| Measure |
Etanercept 50 mg - Period 2
n=23 Participants
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 Participants
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 Participants
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
|---|---|---|---|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
DAS28 >3.2 to 5.1 (n= 0, 1, 0)
|
0.0 percentage of participants
|
100 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Number of swollen joints = 0 (n= 18, 21, 19)
|
44.4 percentage of participants
|
57.1 percentage of participants
|
84.2 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Number of swollen joints >0 (n= 5, 6, 4)
|
60.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Number of tender joints = 0 (n= 20, 19, 15)
|
45.0 percentage of participants
|
47.4 percentage of participants
|
86.7 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Number of tender joints >0 to 1 (n= 2, 4, 6)
|
100 percentage of participants
|
75.0 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Number of tender joints > 1 (n= 0, 4, 2)
|
0.0 percentage of participants
|
75.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
DAS28 <=2.6 (n= 20, 21, 18)
|
40.0 percentage of participants
|
47.6 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
DAS28 >2.6 to 3.2 (n= 2, 5, 5)
|
100 percentage of participants
|
80.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
PGA = 0 (n= 6, 4, 9)
|
50.0 percentage of participants
|
25.0 percentage of participants
|
88.9 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
PGA >0 to 3 (n= 5, 10, 3)
|
60.0 percentage of participants
|
60.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
PGA >3 to 7 (n= 9, 5, 5)
|
33.3 percentage of participants
|
40.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
PGA >7 (n= 3, 8, 5)
|
66.7 percentage of participants
|
75.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
PtGA <= 2.5 (n= 6, 8, 5)
|
66.7 percentage of participants
|
37.5 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
PtGA >2.5 to 11 (n= 7, 5, 6)
|
28.6 percentage of participants
|
60.0 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
PtGA >11 to 21 (n= 4, 7, 7)
|
50.0 percentage of participants
|
57.1 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
PtGA >21 (n= 6, 7, 5)
|
50.0 percentage of participants
|
71.4 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Participant general health VAS <=3 (n= 6, 7, 6)
|
50.0 percentage of participants
|
28.6 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Participant general health VAS >3 to 14 (n= 9,8,4)
|
44.4 percentage of participants
|
62.5 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Participant general health VAS>14 to 26.5(n=2,7,7)
|
100 percentage of participants
|
57.1 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Participant general health VAS >26.5 (n= 6, 5, 6)
|
33.3 percentage of participants
|
80.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Participant pain VAS <=3 (n= 7, 8, 5)
|
57.1 percentage of participants
|
37.5 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Participant pain VAS >3 to 10 (n= 6, 5, 6)
|
33.3 percentage of participants
|
20.0 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Participant pain VAS >10 to 22 (n=3, 7, 8)
|
33.3 percentage of participants
|
85.7 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Participant pain VAS >22 (n= 7, 7, 4)
|
57.1 percentage of participants
|
71.4 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
CDAI <= 2.8 (n= 14, 13, 13)
|
50.0 percentage of participants
|
46.2 percentage of participants
|
84.6 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
CDAI >2.8 to 10 (n= 9, 14, 9)
|
44.4 percentage of participants
|
64.3 percentage of participants
|
88.9 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
SDAI<= 3.3 (n= 8, 7, 8)
|
50.0 percentage of participants
|
28.6 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
SDAI>3.3 to 11 (n= 13, 15, 12)
|
38.5 percentage of participants
|
60.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
SDAI>11 to 26 (n= 2, 4, 2)
|
100 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
SDAI>26 (n= 0, 1, 0)
|
0.0 percentage of participants
|
100 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
ESR<= 5 (n= 6, 8, 10)
|
66.7 percentage of participants
|
12.5 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
ESR >5 to 10 (n= 7, 9, 6)
|
28.6 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
ESR >10 to 12.5 (n= 0, 3, 2)
|
0.0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
ESR >12.5 (n= 6, 7, 5)
|
66.7 percentage of participants
|
71.4 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Plasma CRP <= 1 (n= 8, 8, 8)
|
62.5 percentage of participants
|
37.5 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Plasma CRP >1 to 2 (n= 5, 2, 7)
|
20.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Plasma CRP >2 to 5 (n= 6, 11, 3)
|
16.7 percentage of participants
|
54.5 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Plasma CRP >5 (n= 4, 6, 5)
|
100 percentage of participants
|
83.3 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Sensitive serum CRP <= 0.6 (n= 7, 5, 6)
|
57.1 percentage of participants
|
20.0 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Sensitive serum CRP >0.6 to 1.2 (n= 5, 5, 7)
|
40.0 percentage of participants
|
80.0 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Sensitive serum CRP >1.2 to 3.3 (n= 6, 7, 5)
|
33.3 percentage of participants
|
42.9 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Sensitive serum CRP >3.3 (n= 4, 8, 5)
|
75.0 percentage of participants
|
75.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Anti-CCP <= 31.7 (n= 5, 8, 5)
|
40.0 percentage of participants
|
37.5 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Anti-CCP >31.7 to 346.8 (n= 8, 3, 6)
|
75.0 percentage of participants
|
100 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Anti-CCP >346.8 to 710.8 (n= 5, 4, 9)
|
20.0 percentage of participants
|
50.0 percentage of participants
|
77.8 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Anti-CCP >710.8 (n= 4, 10, 3)
|
50.0 percentage of participants
|
60.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
COMP <= 7.6 (n= 7, 5, 6)
|
28.6 percentage of participants
|
20.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
COMP >7.6 to 9.6 (n= 5, 4, 8)
|
60.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
COMP >9.6 to 12.3 (n= 5, 11, 2)
|
80.0 percentage of participants
|
63.6 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
COMP >12.3 (n= 5, 5, 7)
|
40.0 percentage of participants
|
80.0 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
S-score <= 1.5 (n= 5, 5, 5)
|
20.0 percentage of participants
|
40.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
S-score >1.5 to 3.8 (n= 5, 2, 5)
|
20.0 percentage of participants
|
50.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
S-score >3.8 to 7.5 (n= 5, 8, 1)
|
80.0 percentage of participants
|
37.5 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
S-score >7.5 (n= 3, 6, 4)
|
66.7 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
O-score <= 0.5 (n= 6, 7, 4)
|
16.7 percentage of participants
|
42.9 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
O-score >0.5 to 1.5 (n= 4, 6, 2)
|
25.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
O-score >1.5 to 3.5 (n= 7, 0, 3)
|
71.4 percentage of participants
|
0.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
O-score >3.5 (n= 1, 6, 6)
|
100 percentage of participants
|
50.0 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
E-score <= 3.0 (n= 7, 5, 5)
|
14.3 percentage of participants
|
20.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
E-score >3.0 to 9.8 (n= 4, 4, 2)
|
75.0 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
E-score >9.8 to 23.0 (n= 5, 4, 5)
|
60.0 percentage of participants
|
50.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
E-score >23.0 (n= 2, 8, 3)
|
50.0 percentage of participants
|
62.5 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Joint space narrowing score <= 0.5 (n= 5, 7, 5)
|
20.0 percentage of participants
|
28.6 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Joint space narrowing score >0.5 to 9.0 (n=5,0,6)
|
60.0 percentage of participants
|
0.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Joint space narrowing score >9.0 to 23.5 (n=7,4,3)
|
57.1 percentage of participants
|
75.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Joint space narrowing score >23.5 (n= 2, 9, 3)
|
50.0 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Erosion score <= 9.0 (n= 7, 0, 3)
|
42.9 percentage of participants
|
0.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Erosion score >9.0 to 21.3 (n= 4, 3, 7)
|
25.0 percentage of participants
|
66.7 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Erosion score >21.3 to 47.5 (n= 5, 6, 4)
|
40.0 percentage of participants
|
50.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Erosion score >47.5 (n= 3, 8, 3)
|
100 percentage of participants
|
75.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
mTSS <= 10.0 (n= 5, 6, 4)
|
20.0 percentage of participants
|
16.7 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
mTSS >10.0 to 31.5 (n= 5, 3, 6)
|
60.0 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
mTSS >31.5 to 70.0 (n= 7, 4, 4)
|
42.9 percentage of participants
|
75.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
mTSS >70.0 (n= 2, 9, 3)
|
100 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
Adverse Events
Etanercept 50 mg - Period 1
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Etanercept 50 mg - Period 2
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Etanercept 25 mg - Period 2
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo - Period 2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Etanercept 50 mg - Period 3
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept 50 mg - Period 1
n=91 participants at risk
Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (\<=) 3.2 in Period 1 were randomized in Period 2.
|
Etanercept 50 mg - Period 2
n=23 participants at risk
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 participants at risk
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 participants at risk
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 50 mg - Period 3
n=43 participants at risk
Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
|
|---|---|---|---|---|---|
|
Infections and infestations
Endometritis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Etanercept 50 mg - Period 1
n=91 participants at risk
Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (\<=) 3.2 in Period 1 were randomized in Period 2.
|
Etanercept 50 mg - Period 2
n=23 participants at risk
Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than \[\>\] 5.1, or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 more than or equal to \[\>=\] 1.2, or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 25 mg - Period 2
n=27 participants at risk
Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Placebo - Period 2
n=23 participants at risk
Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 \>5.1 or DAS28 \>3.2 but \<=5.1 along with an increase from baseline in DAS28 \>=1.2 or DAS28 \>3.2 along with an increase from baseline \>=0.6 but \<1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
|
Etanercept 50 mg - Period 3
n=43 participants at risk
Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
7/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
26.1%
6/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
29.6%
8/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.7%
2/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
18.6%
8/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
2/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
26.1%
6/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.1%
3/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.7%
2/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.9%
9/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Conjunctivitis bacterial
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Laryngitis
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
3/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.0%
3/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
2/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.7%
2/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.1%
3/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Adverse drug reaction
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Discomfort
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
2/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.4%
2/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Arrhythmia
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.1%
3/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Paronychia
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.0%
3/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Skin infection
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Eye infection
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid nodule
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.1%
3/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site reaction
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Local swelling
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.4%
2/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.0%
3/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.7%
2/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Dental operation
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Toe operation
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Photokeratitis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.4%
2/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
1/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
1/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of eyelid
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/91
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/27
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/23
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
1/43
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER