Trial Outcomes & Findings for An Open Label Study for Participants With Rheumatoid Arthritis (NCT NCT01215942)
NCT ID: NCT01215942
Last Updated: 2018-06-11
Results Overview
A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1086 participants
Primary outcome timeframe
up to 84.4 weeks during treatment period
Results posted on
2018-06-11
Participant Flow
Study consisted of a Treatment Period of up to 240 weeks for participants (pts) who enrolled from Studies H9B-MC-BCDO (BCDO) (NCT01202760) and H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for pts who enrolled from Study H9-MC-BCDM (BCDM) (NCT01198002). Discontinued pts were followed in Post-Treatment Follow-Up Period for up to 48 weeks.
Participant milestones
| Measure |
120 mg LY2127399 (LY A)
120 milligrams (mg) LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W).
Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study H9B-MC-BCDP (BCDP) enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
|
90 mg LY2127399 (LY B)
90 mg LY2127399 administered SC every 2 weeks (Q2W).
Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
|
|---|---|---|
|
Treatment Period
STARTED
|
414
|
672
|
|
Treatment Period
COMPLETED
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
414
|
672
|
|
Post-Treatment Follow-Up Period
STARTED
|
368
|
591
|
|
Post-Treatment Follow-Up Period
COMPLETED
|
283
|
445
|
|
Post-Treatment Follow-Up Period
NOT COMPLETED
|
85
|
146
|
Reasons for withdrawal
| Measure |
120 mg LY2127399 (LY A)
120 milligrams (mg) LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W).
Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study H9B-MC-BCDP (BCDP) enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
|
90 mg LY2127399 (LY B)
90 mg LY2127399 administered SC every 2 weeks (Q2W).
Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
|
|---|---|---|
|
Treatment Period
Adverse Event
|
15
|
26
|
|
Treatment Period
Death
|
2
|
4
|
|
Treatment Period
Lack of Efficacy
|
23
|
62
|
|
Treatment Period
Lost to Follow-up
|
3
|
4
|
|
Treatment Period
Withdrawal by Subject
|
17
|
40
|
|
Treatment Period
Physician Decision
|
5
|
5
|
|
Treatment Period
Protocol Violation
|
0
|
1
|
|
Treatment Period
Sponsor Decision
|
349
|
530
|
|
Post-Treatment Follow-Up Period
Death
|
0
|
1
|
|
Post-Treatment Follow-Up Period
Lost to Follow-up
|
13
|
13
|
|
Post-Treatment Follow-Up Period
Withdrawal by Subject
|
43
|
69
|
|
Post-Treatment Follow-Up Period
Physician Decision
|
1
|
2
|
|
Post-Treatment Follow-Up Period
Sponsor Decision
|
28
|
61
|
Baseline Characteristics
An Open Label Study for Participants With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
120 mg LY2127399 (LY A)
n=414 Participants
120 mg LY2127399 administered SC Q4W.
Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
|
90 mg LY2127399 (LY B)
n=672 Participants
90 mg LY2127399 administered SC Q2W.
Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
|
Total
n=1086 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
339 Participants
n=5 Participants
|
538 Participants
n=7 Participants
|
877 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
218 Participants
n=5 Participants
|
365 Participants
n=7 Participants
|
583 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
144 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
17 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
82 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
285 Participants
n=5 Participants
|
450 Participants
n=7 Participants
|
735 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
148 Participants
n=5 Participants
|
294 Participants
n=7 Participants
|
442 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
12 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
12 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
13 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
Sri Lanka
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
23 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
42 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
44 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 84.4 weeks during treatment periodPopulation: All enrolled participants.
A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
120 mg LY2127399 (LY A)
n=414 Participants
120 mg LY2127399 administered SC Q4W.
Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
|
90 mg LY2127399 (LY B)
n=672 Participants
90 mg LY2127399 administered SC Q2W.
Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
|
NR LY A to LY B
90 mg LY2127399 administered SC Q2W.
All Week 16 non-responders (NR) from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR LY B to LY B
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR Placebo to LY B
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
Placebo to LY A
120 mg LY2127399 administered SC Q4W (240 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 120 mg LY2127399 SC Q4W in Study BCDP.
|
Placebo to LY B
90 mg LY2127399 administered SC Q2W (180 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 90 mg LY2127399 SC Q2W in Study BCDP.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
TEAE
|
259 Participants
|
422 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
SAE
|
30 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
Infection
|
127 Participants
|
266 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
Injection site reaction
|
15 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
Malignancy
|
0 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
MACE
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
Allergy and hypersensitivity
|
13 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
Depression
|
7 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
Suicide/Self-injury
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
Pregnancy
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through Weeks 4, 24, 48 and 72Population: All participants from Studies BCDO and BCDV with an evaluable baseline anti-LY2127399 antibodies result and a post-baseline anti-LY2127399 antibodies result. Participants missing an evaluable baseline result with a negative post-baseline results were included.
Participants with treatment-emergent anti-LY2127399 antibodies were participants who had any samples from baseline up to and through Week 72 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). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants with anti-LY2127399 antibodies=(number of participants with treatment-emergent anti-LY2127399 antibodies / number of participants assessed)\*100.
Outcome measures
| Measure |
120 mg LY2127399 (LY A)
n=291 Participants
120 mg LY2127399 administered SC Q4W.
Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
|
90 mg LY2127399 (LY B)
n=292 Participants
90 mg LY2127399 administered SC Q2W.
Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
|
NR LY A to LY B
n=88 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 non-responders (NR) from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR LY B to LY B
n=88 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR Placebo to LY B
n=67 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
Placebo to LY A
n=97 Participants
120 mg LY2127399 administered SC Q4W (240 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 120 mg LY2127399 SC Q4W in Study BCDP.
|
Placebo to LY B
n=102 Participants
90 mg LY2127399 administered SC Q2W (180 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 90 mg LY2127399 SC Q2W in Study BCDP.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Developing Anti-LY2127399 Antibodies
Week 4
|
1.7 percentage of participants
|
0.3 percentage of participants
|
3.4 percentage of participants
|
1.1 percentage of participants
|
1.5 percentage of participants
|
2.1 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants Developing Anti-LY2127399 Antibodies
Week 24
|
0.7 percentage of participants
|
0.7 percentage of participants
|
1.3 percentage of participants
|
1.4 percentage of participants
|
0.0 percentage of participants
|
1.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Developing Anti-LY2127399 Antibodies
Week 48
|
0.0 percentage of participants
|
0.6 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Developing Anti-LY2127399 Antibodies
Week 72
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: All participants from Studies BCDO and BCDV with an evaluable CD3-CD20+ B cell counts. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
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 in preceding studies, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively, in B cell count.
Outcome measures
| Measure |
120 mg LY2127399 (LY A)
n=302 Participants
120 mg LY2127399 administered SC Q4W.
Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
|
90 mg LY2127399 (LY B)
n=305 Participants
90 mg LY2127399 administered SC Q2W.
Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
|
NR LY A to LY B
n=90 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 non-responders (NR) from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR LY B to LY B
n=88 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR Placebo to LY B
n=70 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
Placebo to LY A
n=102 Participants
120 mg LY2127399 administered SC Q4W (240 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 120 mg LY2127399 SC Q4W in Study BCDP.
|
Placebo to LY B
n=105 Participants
90 mg LY2127399 administered SC Q2W (180 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 90 mg LY2127399 SC Q2W in Study BCDP.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Absolute B Cell Counts
|
-111.68 cells/microliter (cells/µL)
Standard Deviation 155.59
|
-121.30 cells/microliter (cells/µL)
Standard Deviation 132.68
|
-134.68 cells/microliter (cells/µL)
Standard Deviation 130.21
|
-110.92 cells/microliter (cells/µL)
Standard Deviation 125.30
|
-99.67 cells/microliter (cells/µL)
Standard Deviation 126.55
|
-75.92 cells/microliter (cells/µL)
Standard Deviation 142.78
|
-104.67 cells/microliter (cells/µL)
Standard Deviation 143.24
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: All participants from Studies BCDO and BCDV with an evaluable serum Ig data. LOCF was used to impute missing post-baseline values.
Immunoglobulins (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 serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP.
Outcome measures
| Measure |
120 mg LY2127399 (LY A)
n=306 Participants
120 mg LY2127399 administered SC Q4W.
Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
|
90 mg LY2127399 (LY B)
n=307 Participants
90 mg LY2127399 administered SC Q2W.
Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
|
NR LY A to LY B
n=90 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 non-responders (NR) from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR LY B to LY B
n=91 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR Placebo to LY B
n=71 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
Placebo to LY A
n=104 Participants
120 mg LY2127399 administered SC Q4W (240 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 120 mg LY2127399 SC Q4W in Study BCDP.
|
Placebo to LY B
n=105 Participants
90 mg LY2127399 administered SC Q2W (180 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 90 mg LY2127399 SC Q2W in Study BCDP.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Immunoglobulin (Ig) Levels
IgA
|
-0.402 grams/liter (g/L)
Standard Deviation 0.580
|
-0.424 grams/liter (g/L)
Standard Deviation 0.604
|
-0.499 grams/liter (g/L)
Standard Deviation 0.681
|
-0.465 grams/liter (g/L)
Standard Deviation 0.501
|
-0.298 grams/liter (g/L)
Standard Deviation 0.376
|
-0.300 grams/liter (g/L)
Standard Deviation 0.590
|
-0.407 grams/liter (g/L)
Standard Deviation 0.481
|
|
Change From Baseline in Serum Immunoglobulin (Ig) Levels
IgG
|
-1.465 grams/liter (g/L)
Standard Deviation 2.112
|
-1.366 grams/liter (g/L)
Standard Deviation 2.166
|
-1.321 grams/liter (g/L)
Standard Deviation 2.071
|
-1.196 grams/liter (g/L)
Standard Deviation 2.276
|
-1.420 grams/liter (g/L)
Standard Deviation 1.651
|
-1.376 grams/liter (g/L)
Standard Deviation 2.295
|
-1.415 grams/liter (g/L)
Standard Deviation 2.163
|
|
Change From Baseline in Serum Immunoglobulin (Ig) Levels
IgM
|
-0.346 grams/liter (g/L)
Standard Deviation 0.372
|
-0.332 grams/liter (g/L)
Standard Deviation 0.465
|
-0.422 grams/liter (g/L)
Standard Deviation 0.505
|
-0.387 grams/liter (g/L)
Standard Deviation 0.267
|
-0.287 grams/liter (g/L)
Standard Deviation 0.228
|
-0.256 grams/liter (g/L)
Standard Deviation 0.289
|
-0.267 grams/liter (g/L)
Standard Deviation 0.298
|
SECONDARY outcome
Timeframe: Baseline through Weeks 12, 24 and 48Population: All participants from Studies BCDO and BCDV with an evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR20 was missing after carrying forward CRP, last post-baseline ACR20 response was used.
ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥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). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants achieving ACR20 response=(number of ACR20 responders / number of participants treated) \* 100. All participants who discontinue study treatment for any reason were defined as NR at that time point and going forward.
Outcome measures
| Measure |
120 mg LY2127399 (LY A)
n=308 Participants
120 mg LY2127399 administered SC Q4W.
Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
|
90 mg LY2127399 (LY B)
n=308 Participants
90 mg LY2127399 administered SC Q2W.
Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
|
NR LY A to LY B
n=91 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 non-responders (NR) from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR LY B to LY B
n=92 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR Placebo to LY B
n=72 Participants
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
Placebo to LY A
n=105 Participants
120 mg LY2127399 administered SC Q4W (240 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 120 mg LY2127399 SC Q4W in Study BCDP.
|
Placebo to LY B
n=106 Participants
90 mg LY2127399 administered SC Q2W (180 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 90 mg LY2127399 SC Q2W in Study BCDP.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology 20% Response (ACR20)
Week 12
|
41.9 percentage of participants
|
46.1 percentage of participants
|
30.8 percentage of participants
|
21.7 percentage of participants
|
25.0 percentage of participants
|
8.6 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology 20% Response (ACR20)
Week 24
|
37.3 percentage of participants
|
37.0 percentage of participants
|
29.7 percentage of participants
|
16.3 percentage of participants
|
27.8 percentage of participants
|
6.7 percentage of participants
|
9.4 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology 20% Response (ACR20)
Week 48
|
14.0 percentage of participants
|
15.9 percentage of participants
|
18.7 percentage of participants
|
7.6 percentage of participants
|
16.7 percentage of participants
|
6.7 percentage of participants
|
5.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 240 weeksPopulation: Zero participants analyzed. DAS28-CRP data was not collected for analysis due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 240 weeksPopulation: Zero participants analyzed. EULAR-28 data was not collected for analysis due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 240 weeksPopulation: Zero participants analyzed. SF-36 data was not collected for analysis due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 240 weeksPopulation: Zero participants analyzed. Tender joint count data was not collected for analysis due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 240 weeksPopulation: Zero participants analyzed. Swollen joint count data was not collected for analysis due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 240 weeksPopulation: Zero participants analyzed. VAS data was not collected for analysis due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 240 weeksPopulation: Zero participants analyzed. Participants Global assessment data was not collected for analysis due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 240 weeksPopulation: Zero participants analyzed. Physicians global assessment data was not collected for analysis due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 240 weeksPopulation: Zero participants analyzed. HAQ-DI data was not collected for analysis due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 240 weeksPopulation: Zero participants analyzed. CRP data was not collected for analysis due to early termination of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 240 weeksPopulation: Zero participants analyzed. ACR-N data was not collected for analysis due to early termination of the study.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 84.4 weeks during treatment period and discontinuation from study treatment up to 48 weeks during follow-up periodPopulation: All enrolled participants.
Outcome measures
| Measure |
120 mg LY2127399 (LY A)
n=414 Participants
120 mg LY2127399 administered SC Q4W.
Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
|
90 mg LY2127399 (LY B)
n=672 Participants
90 mg LY2127399 administered SC Q2W.
Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
|
NR LY A to LY B
90 mg LY2127399 administered SC Q2W.
All Week 16 non-responders (NR) from Studies BCDO and BCDV who were randomized to 120 mg LY2127399 SC Q4W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR LY B to LY B
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to 90 mg LY2127399 SC Q2W at Week 0 of Studies BCDO and BCDV and continued to receive 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
NR Placebo to LY B
90 mg LY2127399 administered SC Q2W.
All Week 16 NR from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and assigned to 90 mg LY2127399 SC Q2W at Week 16 of Studies BCDO and BCDV.
|
Placebo to LY A
120 mg LY2127399 administered SC Q4W (240 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 120 mg LY2127399 SC Q4W in Study BCDP.
|
Placebo to LY B
90 mg LY2127399 administered SC Q2W (180 mg LY2127399 loading dose at Week 0).
All Week 16 responders from Studies BCDO and BCDV who were randomized to placebo SC Q2W at Week 0 of Studies BCDO and BCDV and were randomized to receive 90 mg LY2127399 SC Q2W in Study BCDP.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Died During Treatment Period and Post-Treatment Follow-Up Period
Treatment Period
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Died During Treatment Period and Post-Treatment Follow-Up Period
Post-Treatment Follow-Up Period
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
120 mg LY2127399 (LY A) Treatment Period
Serious events: 30 serious events
Other events: 130 other events
Deaths: 0 deaths
90 mg LY2127399 (LY B) Treatment Period
Serious events: 57 serious events
Other events: 251 other events
Deaths: 0 deaths
120 mg LY2127399 (LY A) Follow-Up Period
Serious events: 15 serious events
Other events: 47 other events
Deaths: 0 deaths
90 mg LY2127399 (LY B) Follow-Up Period
Serious events: 28 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
120 mg LY2127399 (LY A) Treatment Period
n=414 participants at risk
120 mg LY2127399 administered SC Q4W.
Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
|
90 mg LY2127399 (LY B) Treatment Period
n=672 participants at risk
90 mg LY2127399 administered SC Q2W.
Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
|
120 mg LY2127399 (LY A) Follow-Up Period
n=368 participants at risk
The Post-Treatment Follow-Up Period was defined as the time after study treatment discontinuation visit up to 48 weeks following the last injection of study treatment.
Includes Participants who were previously enrolled in Studies BCDO, BCDV and BCDM and who received 120 mg LY2127399 SC Q4W during Study BCDP treatment period.
|
90 mg LY2127399 (LY B) Follow-Up Period
n=591 participants at risk
The Post-Treatment Follow-Up Period was defined as the time after study treatment discontinuation visit up to 48 weeks following the last injection of study treatment.
Includes Participants who were previously enrolled in Studies BCDO, BCDV and BCDM and who received 90 mg LY2127399 SC Q2W during Study BCDP treatment period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Cardiac disorders
Acute myocardial infarction
|
0.24%
1/414 • Number of events 1
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Cardiac disorders
Atrial fibrillation
|
0.72%
3/414 • Number of events 3
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Cardiac disorders
Cardiac failure congestive
|
0.48%
2/414 • Number of events 2
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Cardiac disorders
Coronary artery disease
|
0.24%
1/414 • Number of events 1
|
0.30%
2/672 • Number of events 2
|
0.00%
0/368
|
0.00%
0/591
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Cardiac disorders
Palpitations
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Eye disorders
Maculopathy
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/414
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.00%
0/414
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Gastrointestinal disorders
Dyspepsia
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/414
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Gastrointestinal disorders
Pancreatitis
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/414
|
0.30%
2/672 • Number of events 2
|
0.00%
0/368
|
0.00%
0/591
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
General disorders
Chest pain
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
General disorders
Non-cardiac chest pain
|
0.24%
1/414 • Number of events 1
|
0.30%
2/672 • Number of events 2
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
General disorders
Ulcer haemorrhage
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.34%
2/591 • Number of events 2
|
|
Infections and infestations
Abscess limb
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Bronchiolitis
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Cellulitis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Infected bunion
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Influenza
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Klebsiella infection
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/339
|
0.00%
0/538
|
0.00%
0/301
|
0.21%
1/473 • Number of events 1
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.24%
1/414 • Number of events 1
|
0.15%
1/672 • Number of events 1
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.48%
2/414 • Number of events 2
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Septic shock
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Soft tissue infection
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/414
|
0.15%
1/672 • Number of events 2
|
0.00%
0/368
|
0.17%
1/591 • Number of events 2
|
|
Infections and infestations
Subcutaneous abscess
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Urinary tract infection
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Urosepsis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Infections and infestations
Wound infection
|
0.00%
0/414
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.34%
2/591 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/414
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/414
|
0.30%
2/672 • Number of events 2
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/414
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.24%
1/414 • Number of events 1
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Metabolism and nutrition disorders
Dehydration
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/414
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.24%
1/414 • Number of events 1
|
0.30%
2/672 • Number of events 2
|
0.27%
1/368 • Number of events 1
|
0.51%
3/591 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.48%
2/414 • Number of events 2
|
0.74%
5/672 • Number of events 5
|
0.54%
2/368 • Number of events 2
|
0.51%
3/591 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/414
|
0.30%
2/672 • Number of events 3
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/339
|
0.19%
1/538 • Number of events 1
|
0.00%
0/301
|
0.00%
0/473
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/414
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/75
|
0.00%
0/134
|
0.00%
0/67
|
0.85%
1/118 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/339
|
0.00%
0/538
|
0.00%
0/301
|
0.21%
1/473 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/414
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Nervous system disorders
Transient ischaemic attack
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Nervous system disorders
Vertebral artery dissection
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/339
|
0.19%
1/538 • Number of events 1
|
0.00%
0/301
|
0.00%
0/473
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/339
|
0.19%
1/538 • Number of events 1
|
0.00%
0/301
|
0.00%
0/473
|
|
Psychiatric disorders
Depression
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Psychiatric disorders
Schizoaffective disorder bipolar type
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Renal and urinary disorders
Renal failure acute
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/339
|
0.19%
1/538 • Number of events 1
|
0.00%
0/301
|
0.00%
0/473
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/414
|
0.00%
0/672
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.24%
1/414 • Number of events 1
|
0.30%
2/672 • Number of events 2
|
0.00%
0/368
|
0.00%
0/591
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Vascular disorders
Aortic stenosis
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Vascular disorders
Arterial haemorrhage
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.00%
0/368
|
0.00%
0/591
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Vascular disorders
Deep vein thrombosis
|
0.24%
1/414 • Number of events 1
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
|
Vascular disorders
Hypertension
|
0.24%
1/414 • Number of events 1
|
0.00%
0/672
|
0.27%
1/368 • Number of events 1
|
0.00%
0/591
|
|
Vascular disorders
Hypotension
|
0.00%
0/414
|
0.15%
1/672 • Number of events 1
|
0.00%
0/368
|
0.00%
0/591
|
Other adverse events
| Measure |
120 mg LY2127399 (LY A) Treatment Period
n=414 participants at risk
120 mg LY2127399 administered SC Q4W.
Participants from Studies BCDO, BCDV and BCDM who were on 120 mg LY2127399 SC Q4W immediately prior to Study BCDP enrollment remained on 120 mg LY2127399 SC Q4W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 240 mg LY2127399 SC, 4 weeks later followed by 120 mg LY2127399 SC Q4W for the subsequent treatment.
|
90 mg LY2127399 (LY B) Treatment Period
n=672 participants at risk
90 mg LY2127399 administered SC Q2W.
Participants from Studies BCDO, BCDV and BCDM who were on 90 mg LY2127399 SC Q2W immediately prior to Study BCDP enrollment remained on 90 mg LY2127399 SC Q2W. Participants from Studies BCDO, BCDV and BCDM who were on placebo immediately prior to Study BCDP enrollment were randomized to receive a loading dose of 180 mg LY2127399 SC, 2 weeks later followed by 90 mg LY2127399 SC Q2W for the subsequent treatment.
|
120 mg LY2127399 (LY A) Follow-Up Period
n=368 participants at risk
The Post-Treatment Follow-Up Period was defined as the time after study treatment discontinuation visit up to 48 weeks following the last injection of study treatment.
Includes Participants who were previously enrolled in Studies BCDO, BCDV and BCDM and who received 120 mg LY2127399 SC Q4W during Study BCDP treatment period.
|
90 mg LY2127399 (LY B) Follow-Up Period
n=591 participants at risk
The Post-Treatment Follow-Up Period was defined as the time after study treatment discontinuation visit up to 48 weeks following the last injection of study treatment.
Includes Participants who were previously enrolled in Studies BCDO, BCDV and BCDM and who received 90 mg LY2127399 SC Q2W during Study BCDP treatment period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
6/414 • Number of events 6
|
2.2%
15/672 • Number of events 15
|
0.82%
3/368 • Number of events 3
|
0.68%
4/591 • Number of events 4
|
|
General disorders
Injection site reaction
|
1.7%
7/414 • Number of events 10
|
2.4%
16/672 • Number of events 44
|
0.00%
0/368
|
0.17%
1/591 • Number of events 9
|
|
Infections and infestations
Bronchitis
|
3.6%
15/414 • Number of events 15
|
4.5%
30/672 • Number of events 36
|
1.4%
5/368 • Number of events 7
|
2.2%
13/591 • Number of events 13
|
|
Infections and infestations
Influenza
|
1.4%
6/414 • Number of events 6
|
2.7%
18/672 • Number of events 19
|
0.82%
3/368 • Number of events 3
|
0.51%
3/591 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
21/414 • Number of events 32
|
5.7%
38/672 • Number of events 44
|
3.3%
12/368 • Number of events 17
|
2.0%
12/591 • Number of events 14
|
|
Infections and infestations
Sinusitis
|
4.1%
17/414 • Number of events 19
|
3.4%
23/672 • Number of events 26
|
0.82%
3/368 • Number of events 3
|
1.9%
11/591 • Number of events 12
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
23/414 • Number of events 36
|
10.9%
73/672 • Number of events 89
|
2.2%
8/368 • Number of events 8
|
1.9%
11/591 • Number of events 11
|
|
Infections and infestations
Urinary tract infection
|
3.9%
16/414 • Number of events 19
|
2.5%
17/672 • Number of events 22
|
0.54%
2/368 • Number of events 2
|
0.85%
5/591 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
16/414 • Number of events 19
|
3.7%
25/672 • Number of events 27
|
0.82%
3/368 • Number of events 3
|
0.34%
2/591 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
9/414 • Number of events 9
|
0.89%
6/672 • Number of events 7
|
0.54%
2/368 • Number of events 2
|
0.34%
2/591 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
6.3%
26/414 • Number of events 33
|
8.8%
59/672 • Number of events 65
|
2.7%
10/368 • Number of events 10
|
2.5%
15/591 • Number of events 21
|
|
Nervous system disorders
Headache
|
2.7%
11/414 • Number of events 11
|
1.3%
9/672 • Number of events 11
|
0.27%
1/368 • Number of events 1
|
0.51%
3/591 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
10/414 • Number of events 11
|
1.9%
13/672 • Number of events 14
|
0.00%
0/368
|
0.17%
1/591 • Number of events 1
|
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