Trial Outcomes & Findings for A Study in Participants With Rheumatoid Arthritis (NCT NCT01202773)
NCT ID: NCT01202773
Last Updated: 2018-05-14
Results Overview
ACR Responder Index: composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: a ≥20% improvement from baseline in both 68 tender joint counts (TJC) and 66 swollen joint counts (SJC) and a ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response = (number of ACR20 responders / number of participants treated) \* 100. All NR at Week 16, as well as all participants who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
456 participants
Primary outcome timeframe
Baseline through Week 24
Results posted on
2018-05-14
Participant Flow
Study had a treatment period (Weeks 0-24) and a post-treatment follow-up period (24-48 weeks in length). All participants were assessed for nonresponse at Week 16 with non-responders (NR) defined as participants with \<20% improvement from baseline in both tender and swollen joint counts.
Participant milestones
| Measure |
120 mg LY2127399
A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W) for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W).
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks.
At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
153
|
148
|
155
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
153
|
147
|
154
|
|
Overall Study
Week 16 NR
|
23
|
33
|
37
|
|
Overall Study
Post-Treatment Follow-Up Population
|
46
|
36
|
51
|
|
Overall Study
COMPLETED
|
96
|
105
|
100
|
|
Overall Study
NOT COMPLETED
|
57
|
43
|
55
|
Reasons for withdrawal
| Measure |
120 mg LY2127399
A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W) for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W).
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks.
At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
5
|
5
|
|
Overall Study
Lack of Efficacy
|
5
|
4
|
9
|
|
Overall Study
Entry Criteria Not Met
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
13
|
6
|
5
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
11
|
6
|
10
|
|
Overall Study
Sponsor Decision
|
19
|
20
|
23
|
Baseline Characteristics
A Study in Participants With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
120 mg LY2127399
n=153 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
90 mg LY2127399
n=148 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks.
At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=155 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Total
n=456 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
381 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
289 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
119 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
339 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
89 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
268 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
Colombia
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
Malaysia
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
New Zealand
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 24Population: All randomized participants with evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.
ACR Responder Index: composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: a ≥20% improvement from baseline in both 68 tender joint counts (TJC) and 66 swollen joint counts (SJC) and a ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response = (number of ACR20 responders / number of participants treated) \* 100. All NR at Week 16, as well as all participants who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
Outcome measures
| Measure |
120 mg LY2127399
n=153 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=148 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=155 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
|
17.6 percentage of participants
|
24.3 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: All randomized participants with evaluable ACR50 or ACR70 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.
ACR Responder Index: composite of clinical, laboratory, and functional measures of RA. ACR50 Responder: had a ≥50% improvement from baseline in both 68 TJC and 66 SJC and a ≥50% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response = \[number (No.) of ACR50 responders / No. of Pts treated\]\*100. ACR70 Responder: had a ≥70% improvement from baseline in both TJC and SJC and a ≥70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response = (No. of ACR70 responders / No. of Pts treated)\*100. All NR at Week 16, as well as all Pts who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
Outcome measures
| Measure |
120 mg LY2127399
n=153 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=148 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=155 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
ACR50
|
7.2 percentage of participants
|
5.4 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
ACR70
|
2.6 percentage of participants
|
2.0 percentage of participants
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: All randomized participants with evaluable ACR-N data. Modified Baseline Observation Carried Forward (mBOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJC, b) % change in SJC, or c) the median % change of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline Disease Activity Score based on 28 joint counts -CRP (DAS28-CRP) as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=153 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=146 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=153 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
American College of Rheumatology Percent Improvement (ACR-N)
|
-9.03 percentage of improvement
Standard Error 4.00
|
-8.03 percentage of improvement
Standard Error 4.11
|
-12.72 percentage of improvement
Standard Error 4.00
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable tender joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=153 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=147 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=154 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Tender Joint Count (68 Joint Count)
|
-6.37 joint counts
Standard Error 1.40
|
-6.08 joint counts
Standard Error 1.42
|
-6.56 joint counts
Standard Error 1.38
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable swollen joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=153 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=147 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=154 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Swollen Joint Count (66 Joint Count)
|
-6.02 joint counts
Standard Error 0.98
|
-5.64 joint counts
Standard Error 1.00
|
-5.41 joint counts
Standard Error 0.98
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable participant's assessment of pain data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Participant's assessment of their current arthritis pain using VAS ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=153 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=146 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=153 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
|
-9.89 mm
Standard Error 2.10
|
-9.15 mm
Standard Error 2.15
|
-5.76 mm
Standard Error 2.10
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable participant's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Participant's assessment of their current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=153 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=146 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=153 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Participant's Global Assessment of Disease Activity (VAS)
|
-11.29 mm
Standard Error 2.14
|
-8.72 mm
Standard Error 2.19
|
-7.12 mm
Standard Error 2.13
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable physician's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=147 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=140 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=150 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Physician's Global Assessment of Disease Activity (VAS)
|
-15.90 mm
Standard Error 2.16
|
-16.38 mm
Standard Error 2.23
|
-13.17 mm
Standard Error 2.13
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable HAQ-DI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=153 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=146 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=153 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)
|
-0.13 units on a scale
Standard Error 0.05
|
-0.09 units on a scale
Standard Error 0.05
|
-0.08 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable DAS28-CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter), and participant's global assessment of disease activity using VAS (participant global VAS). DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*participant global VAS+0.96. Scores ranged from 1.0 to 9.4, where lower scores indicated less disease activity and remission is DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=152 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=146 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=152 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
|
-0.76 units on a scale
Standard Error 0.12
|
-0.79 units on a scale
Standard Error 0.13
|
-0.72 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: All randomized participants with evaluable EULAR response data. Modified Last Observation Carried Forward (mLOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
EULAR Responder index categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP=0.56\*sqrt(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*participant global VAS+0.96. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP \>5.1, low disease activity: DAS28-CRP \<3.2, and remission: DAS28-CRP \<2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: \<3.2 or \>1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: \>5.1 or \<0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response = ( number of participants with specific response) / (number of participants analyzed in the group) \* 100.
Outcome measures
| Measure |
120 mg LY2127399
n=152 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=146 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=152 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response
Good
|
11.8 percentage of participants
|
9.6 percentage of participants
|
8.6 percentage of participants
|
|
Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response
Moderate
|
36.2 percentage of participants
|
36.3 percentage of participants
|
36.2 percentage of participants
|
|
Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response
No response
|
52.0 percentage of participants
|
54.1 percentage of participants
|
55.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable SF-36 domain and summary scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. If \< 50% of the questions within a domain were answered, the raw score were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100 with higher score indicating better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=146 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=138 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=149 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
Physical Functioning
|
1.81 units on a scale
Standard Error 0.78
|
1.78 units on a scale
Standard Error 0.82
|
1.00 units on a scale
Standard Error 0.77
|
|
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
Bodily Pain
|
2.36 units on a scale
Standard Error 0.75
|
2.95 units on a scale
Standard Error 0.78
|
1.97 units on a scale
Standard Error 0.74
|
|
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
Role Limitations due to Physical Problems
|
1.92 units on a scale
Standard Error 0.72
|
2.08 units on a scale
Standard Error 0.75
|
0.35 units on a scale
Standard Error 0.72
|
|
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
Role Limitations due to Emotional Problems
|
1.07 units on a scale
Standard Error 0.97
|
2.55 units on a scale
Standard Error 1.01
|
1.19 units on a scale
Standard Error 0.96
|
|
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
General Health Perception
|
1.90 units on a scale
Standard Error 0.64
|
0.91 units on a scale
Standard Error 0.67
|
1.88 units on a scale
Standard Error 0.64
|
|
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
Mental Health
|
0.83 units on a scale
Standard Error 0.85
|
1.57 units on a scale
Standard Error 0.88
|
0.98 units on a scale
Standard Error 0.84
|
|
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
Social Function
|
2.51 units on a scale
Standard Error 0.87
|
1.68 units on a scale
Standard Error 0.91
|
1.32 units on a scale
Standard Error 0.86
|
|
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
Vitality
|
2.71 units on a scale
Standard Error 0.77
|
2.40 units on a scale
Standard Error 0.80
|
2.05 units on a scale
Standard Error 0.76
|
|
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
PCS
|
2.30 units on a scale
Standard Error 0.71
|
1.83 units on a scale
Standard Error 0.74
|
1.21 units on a scale
Standard Error 0.71
|
|
Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
MCS
|
1.22 units on a scale
Standard Error 0.87
|
1.86 units on a scale
Standard Error 0.90
|
1.38 units on a scale
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable BFI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, the first item is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0 = no fatigue and 10 = fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=146 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=138 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=149 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
Fatigue - Now
|
-0.68 units on a scale
Standard Error 0.12
|
-0.55 units on a scale
Standard Error 0.12
|
-0.60 units on a scale
Standard Error 0.12
|
|
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
Fatigue - Usual
|
-0.65 units on a scale
Standard Error 0.11
|
-0.58 units on a scale
Standard Error 0.11
|
-0.56 units on a scale
Standard Error 0.11
|
|
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
Fatigue - Worst
|
-0.75 units on a scale
Standard Error 0.12
|
-0.65 units on a scale
Standard Error 0.12
|
-0.72 units on a scale
Standard Error 0.12
|
|
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
General Activity
|
-0.55 units on a scale
Standard Error 0.12
|
-0.50 units on a scale
Standard Error 0.12
|
-0.52 units on a scale
Standard Error 0.12
|
|
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
Mood
|
-0.54 units on a scale
Standard Error 0.12
|
-0.35 units on a scale
Standard Error 0.12
|
-0.35 units on a scale
Standard Error 0.12
|
|
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
Walking Ability
|
-0.53 units on a scale
Standard Error 0.12
|
-0.38 units on a scale
Standard Error 0.13
|
-0.36 units on a scale
Standard Error 0.12
|
|
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
Normal Work
|
-0.60 units on a scale
Standard Error 0.12
|
-0.46 units on a scale
Standard Error 0.12
|
-0.42 units on a scale
Standard Error 0.12
|
|
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
Relations with Other People
|
-0.41 units on a scale
Standard Error 0.12
|
-0.43 units on a scale
Standard Error 0.12
|
-0.29 units on a scale
Standard Error 0.12
|
|
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
Enjoyment of Life
|
-0.53 units on a scale
Standard Error 0.13
|
-0.55 units on a scale
Standard Error 0.13
|
-0.41 units on a scale
Standard Error 0.13
|
|
Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
Fatigue Impact Subscale
|
-0.52 units on a scale
Standard Error 0.11
|
-0.43 units on a scale
Standard Error 0.11
|
-0.39 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable BPI-SF scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24 hours and pain based on the pain right now, with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in the past 24 hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life \[each item scored from 0 (does not interfere) to 10 (completely interferes)\]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=146 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=138 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=149 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Pain - Worst
|
-0.9 units on a scale
Standard Error 0.2
|
-0.8 units on a scale
Standard Error 0.2
|
-0.4 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Pain - Least
|
-0.5 units on a scale
Standard Error 0.2
|
-0.5 units on a scale
Standard Error 0.2
|
-0.1 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Pain - Average
|
-0.7 units on a scale
Standard Error 0.2
|
-0.7 units on a scale
Standard Error 0.2
|
-0.3 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Pain - Now
|
-0.8 units on a scale
Standard Error 0.2
|
-0.5 units on a scale
Standard Error 0.2
|
-0.3 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
General Activity
|
-0.7 units on a scale
Standard Error 0.2
|
-0.4 units on a scale
Standard Error 0.2
|
-0.3 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Mood
|
-0.6 units on a scale
Standard Error 0.2
|
-0.2 units on a scale
Standard Error 0.2
|
-0.0 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Walking Ability
|
-0.8 units on a scale
Standard Error 0.2
|
-0.4 units on a scale
Standard Error 0.2
|
-0.4 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Normal Work
|
-0.7 units on a scale
Standard Error 0.2
|
-0.4 units on a scale
Standard Error 0.2
|
-0.2 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Relations with Other People
|
-0.3 units on a scale
Standard Error 0.2
|
-0.2 units on a scale
Standard Error 0.2
|
-0.1 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Sleep
|
-0.7 units on a scale
Standard Error 0.2
|
-0.3 units on a scale
Standard Error 0.2
|
-0.4 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Enjoyment of Life
|
-0.7 units on a scale
Standard Error 0.2
|
-0.4 units on a scale
Standard Error 0.2
|
-0.4 units on a scale
Standard Error 0.2
|
|
Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Pain Interference Score
|
-0.6 units on a scale
Standard Error 0.2
|
-0.3 units on a scale
Standard Error 0.2
|
-0.3 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable morning stiffness data; mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=141 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=138 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=139 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Duration of Morning Stiffness (Minutes)
|
-20.6 minutes
Standard Error 11.5
|
-1.0 minutes
Standard Error 11.7
|
-18.0 minutes
Standard Error 11.9
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: Zero participants analyzed. Time to ACR20 data not collected for analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable CD3-CD20+ B cell counts. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=151 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=147 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=154 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Absolute B Cell Counts
|
-55.3 cells/microliter (cells/µL)
Standard Error 9.9
|
-65.8 cells/microliter (cells/µL)
Standard Error 10.1
|
3.2 cells/microliter (cells/µL)
Standard Error 9.8
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable serum Ig data. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
Immunoglobulin (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline in serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=151 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=146 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=153 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in Serum Immunoglobulin (Ig) Levels
IgA
|
-0.330 grams/liter (g/L)
Standard Error 0.049
|
-0.324 grams/liter (g/L)
Standard Error 0.050
|
0.003 grams/liter (g/L)
Standard Error 0.049
|
|
Change From Baseline to Week 24 in Serum Immunoglobulin (Ig) Levels
IgG
|
-0.955 grams/liter (g/L)
Standard Error 0.161
|
-0.978 grams/liter (g/L)
Standard Error 0.163
|
0.058 grams/liter (g/L)
Standard Error 0.158
|
|
Change From Baseline to Week 24 in Serum Immunoglobulin (Ig) Levels
IgM
|
-0.273 grams/liter (g/L)
Standard Error 0.043
|
-0.239 grams/liter (g/L)
Standard Error 0.044
|
-0.019 grams/liter (g/L)
Standard Error 0.042
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: All randomized participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.
Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.
Outcome measures
| Measure |
120 mg LY2127399
n=309 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Population Pharmacokinetics (PK): Constant Clearance
|
4.16 milliliters/hour (mL/h)
Standard Error 3.58 • Interval 3.44 to 3.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: All randomized participants who received at least 1 dose of study drug with an evaluable baseline ADA result and a post-baseline ADA result. Participants missing an evaluable baseline result with all negative post-baseline results were included. Data after Week 16 for Week 16 NR were not included.
Participants with treatment-emergent anti-drug antibody (ADA) were participants who had any sample from baseline up to and through Week 52 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA = (number of participants with treatment-emergent ADA) / (number of participants assessed) \* 100.
Outcome measures
| Measure |
120 mg LY2127399
n=153 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=147 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=154 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Percentage of Participants Developing Anti-LY2127399 Antibodies
|
3.9 percentage of participants
|
4.8 percentage of participants
|
3.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants with evaluable CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.
CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
Outcome measures
| Measure |
120 mg LY2127399
n=152 Participants
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
|
90 mg LY2127399
n=147 Participants
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
|
Placebo
n=154 Participants
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
|
|---|---|---|---|
|
Change From Baseline to Week 24 in CRP
|
2.91 milligrams/liter (mg/L)
Standard Error 1.83
|
0.95 milligrams/liter (mg/L)
Standard Error 1.87
|
2.93 milligrams/liter (mg/L)
Standard Error 1.81
|
Adverse Events
LY 120 mg Q4W, Randomized Treatment Period
Serious events: 7 serious events
Other events: 71 other events
Deaths: 0 deaths
LY 90 mg Q2W, Randomized Treatment Period
Serious events: 6 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo, Randomized Treatment Period
Serious events: 6 serious events
Other events: 61 other events
Deaths: 0 deaths
LY 120 mg Q4W, Rescue Period
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
LY 90 mg Q2W, Rescue Period
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo, Rescue Period
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
LY 120 mg Q4W, Follow-up Period
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
LY 90 mg Q2W, Follow-up Period
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo, Follow-up Period
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo to LY 90 mg Q2W (Week 16), Follow-up Period
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY 120 mg Q4W, Randomized Treatment Period
n=153 participants at risk
A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.
|
LY 90 mg Q2W, Randomized Treatment Period
n=147 participants at risk
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.
|
Placebo, Randomized Treatment Period
n=154 participants at risk
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.
|
LY 120 mg Q4W, Rescue Period
n=23 participants at risk
A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR.
|
LY 90 mg Q2W, Rescue Period
n=33 participants at risk
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 16 weeks.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR.
|
Placebo, Rescue Period
n=37 participants at risk
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 16 weeks.
At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR.
|
LY 120 mg Q4W, Follow-up Period
n=43 participants at risk
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
|
LY 90 mg Q2W, Follow-up Period
n=36 participants at risk
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
|
Placebo, Follow-up Period
n=44 participants at risk
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
|
LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period
n=3 participants at risk
A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
|
Placebo to LY 90 mg Q2W (Week 16), Follow-up Period
n=7 participants at risk
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 16 weeks.
At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/153
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Psychiatric disorders
Somatoform disorder
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/153
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/153
|
0.68%
1/147 • Number of events 2
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Vascular disorders
Hypotension
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/153
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Eye disorders
Retinal detachment
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/153
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Abscess
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Device related infection
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Pneumonia
|
1.3%
2/153 • Number of events 2
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Pyomyositis
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/153
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.3%
2/153 • Number of events 2
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
Other adverse events
| Measure |
LY 120 mg Q4W, Randomized Treatment Period
n=153 participants at risk
A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.
|
LY 90 mg Q2W, Randomized Treatment Period
n=147 participants at risk
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.
|
Placebo, Randomized Treatment Period
n=154 participants at risk
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
The Randomized Treatment Period was defined as the time all data was collected during the treatment period, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.
|
LY 120 mg Q4W, Rescue Period
n=23 participants at risk
A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR.
|
LY 90 mg Q2W, Rescue Period
n=33 participants at risk
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 16 weeks.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR.
|
Placebo, Rescue Period
n=37 participants at risk
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 16 weeks.
At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the treatment period for Week 16 NR.
|
LY 120 mg Q4W, Follow-up Period
n=43 participants at risk
A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 24 weeks. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
|
LY 90 mg Q2W, Follow-up Period
n=36 participants at risk
A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 24 weeks. At Week 16, both responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
|
Placebo, Follow-up Period
n=44 participants at risk
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 24 weeks. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
|
LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period
n=3 participants at risk
A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
|
Placebo to LY 90 mg Q2W (Week 16), Follow-up Period
n=7 participants at risk
A loading dose of 2 injections of placebo followed by maintenance dosing of 1 injection of placebo administered SC Q2W for 16 weeks.
At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
The Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/153
|
0.00%
0/147
|
1.3%
2/154 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Ear pain
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/153
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/153 • Number of events 2
|
1.4%
2/147 • Number of events 2
|
1.9%
3/154 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
3.9%
6/153 • Number of events 6
|
0.68%
1/147 • Number of events 1
|
1.3%
2/154 • Number of events 2
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Oedema mouth
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
3/153 • Number of events 3
|
0.68%
1/147 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
General disorders
Asthenia
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
General disorders
Chest pain
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
General disorders
Chills
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
General disorders
Injection site erythema
|
0.65%
1/153 • Number of events 2
|
2.0%
3/147 • Number of events 3
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
General disorders
Injection site pain
|
1.3%
2/153 • Number of events 6
|
3.4%
5/147 • Number of events 18
|
2.6%
4/154 • Number of events 21
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 2
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
General disorders
Injection site reaction
|
2.6%
4/153 • Number of events 6
|
4.8%
7/147 • Number of events 19
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
8.1%
3/37 • Number of events 10
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
General disorders
Oedema peripheral
|
0.00%
0/153
|
2.7%
4/147 • Number of events 4
|
1.3%
2/154 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
General disorders
Pyrexia
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
1.3%
2/154 • Number of events 3
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Bronchitis
|
1.3%
2/153 • Number of events 2
|
2.0%
3/147 • Number of events 3
|
1.9%
3/154 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Cellulitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Herpes zoster
|
1.3%
2/153 • Number of events 2
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Influenza
|
0.65%
1/153 • Number of events 1
|
2.0%
3/147 • Number of events 3
|
1.3%
2/154 • Number of events 2
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
4/153 • Number of events 4
|
1.4%
2/147 • Number of events 2
|
0.00%
0/154
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/153
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Sinusitis
|
3.3%
5/153 • Number of events 6
|
1.4%
2/147 • Number of events 2
|
4.5%
7/154 • Number of events 7
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
6.8%
3/44 • Number of events 3
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/153
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Tooth infection
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
9/153 • Number of events 10
|
4.8%
7/147 • Number of events 7
|
5.8%
9/154 • Number of events 11
|
4.3%
1/23 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
5.6%
2/36 • Number of events 2
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Infections and infestations
Urinary tract infection
|
3.3%
5/153 • Number of events 5
|
4.1%
6/147 • Number of events 6
|
1.3%
2/154 • Number of events 2
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
4.7%
2/43 • Number of events 2
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/153
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Investigations
Haemoglobin decreased
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Investigations
Lipase increased
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Investigations
Neutrophil count increased
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Investigations
Weight decreased
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Investigations
White blood cell count decreased
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Investigations
White blood cell count increased
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
1.3%
2/154 • Number of events 2
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
3/153 • Number of events 3
|
2.0%
3/147 • Number of events 3
|
1.3%
2/154 • Number of events 2
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
0.00%
0/36
|
2.3%
1/44 • Number of events 3
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/153 • Number of events 2
|
1.4%
2/147 • Number of events 2
|
1.3%
2/154 • Number of events 2
|
0.00%
0/23
|
0.00%
0/33
|
5.4%
2/37 • Number of events 2
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
5.6%
2/36 • Number of events 2
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
2.6%
4/154 • Number of events 5
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 2
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.2%
8/153 • Number of events 9
|
4.8%
7/147 • Number of events 7
|
7.1%
11/154 • Number of events 13
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
5.4%
2/37 • Number of events 2
|
0.00%
0/43
|
5.6%
2/36 • Number of events 2
|
4.5%
2/44 • Number of events 2
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/153
|
0.00%
0/147
|
0.65%
1/154 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
1.3%
2/154 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.3%
2/153 • Number of events 2
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
3.4%
1/29 • Number of events 1
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/11
|
0.00%
0/8
|
0.00%
0/10
|
—
0/0
|
—
0/0
|
|
Nervous system disorders
Dizziness
|
2.0%
3/153 • Number of events 3
|
0.68%
1/147 • Number of events 1
|
1.3%
2/154 • Number of events 2
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
4.6%
7/153 • Number of events 8
|
1.4%
2/147 • Number of events 2
|
3.2%
5/154 • Number of events 5
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Psychiatric disorders
Depression
|
1.3%
2/153 • Number of events 2
|
0.00%
0/147
|
2.6%
4/154 • Number of events 4
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/124
|
0.00%
0/125
|
0.00%
0/130
|
5.3%
1/19 • Number of events 1
|
0.00%
0/28
|
0.00%
0/33
|
0.00%
0/32
|
0.00%
0/28
|
0.00%
0/34
|
0.00%
0/3
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
2.3%
1/43 • Number of events 1
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
3/153 • Number of events 3
|
0.68%
1/147 • Number of events 1
|
1.9%
3/154 • Number of events 3
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
2.8%
1/36 • Number of events 1
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
4.3%
1/23 • Number of events 1
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.6%
4/153 • Number of events 4
|
0.68%
1/147 • Number of events 1
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Vascular disorders
Hypertension
|
1.3%
2/153 • Number of events 2
|
0.68%
1/147 • Number of events 1
|
2.6%
4/154 • Number of events 4
|
0.00%
0/23
|
3.0%
1/33 • Number of events 1
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
0.00%
0/44
|
0.00%
0/3
|
0.00%
0/7
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/153
|
0.00%
0/147
|
0.00%
0/154
|
0.00%
0/23
|
0.00%
0/33
|
0.00%
0/37
|
0.00%
0/43
|
0.00%
0/36
|
2.3%
1/44 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60