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Trial Outcomes & Findings for A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy (NCT NCT00785928)

NCT ID: NCT00785928

Last Updated: 2018-07-10

Results Overview

ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR50 Responder is defined as a participant with \>50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

158 participants

Primary outcome timeframe

Up to week 24

Results posted on

2018-07-10

Participant Flow

Participants received a total of 6 subcutaneous (SC) injections (Weeks 0, 4, 8, 12, 16, and 20) of either placebo or 1 of 6 LY2127399 doses (1, 3, 10, 30, 60, or 120 milligrams \[mg\]) during the Treatment Phase. The Follow-up Phase took place Weeks 24-44 and the B-cell Follow-up Phase took place Weeks 44-72.

Participant milestones

Participant milestones
Measure
Placebo
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Treatment Phase
STARTED
36
30
20
15
18
13
26
Treatment Phase
COMPLETED
33
25
17
15
16
13
23
Treatment Phase
NOT COMPLETED
3
5
3
0
2
0
3
Follow-up Phases (Weeks 24-72)
STARTED
8
8
6
4
6
0
14
Follow-up Phases (Weeks 24-72)
COMPLETED
7
5
4
4
4
0
9
Follow-up Phases (Weeks 24-72)
NOT COMPLETED
1
3
2
0
2
0
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Treatment Phase
Adverse Event
1
1
2
0
0
0
2
Treatment Phase
Inadequate Response
0
1
0
0
0
0
0
Treatment Phase
Lack of Efficacy
0
1
1
0
0
0
0
Treatment Phase
Physician Decision
0
0
0
0
1
0
0
Treatment Phase
Sponsor Decision
1
0
0
0
0
0
1
Treatment Phase
Withdrawal by Subject
1
2
0
0
1
0
0

Baseline Characteristics

A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=26 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Total
n=158 Participants
Total of all reporting groups
Age, Continuous
50.6 years
STANDARD_DEVIATION 11.74 • n=5 Participants
54.6 years
STANDARD_DEVIATION 11.67 • n=7 Participants
53.4 years
STANDARD_DEVIATION 10.78 • n=5 Participants
51.2 years
STANDARD_DEVIATION 13.78 • n=4 Participants
54.5 years
STANDARD_DEVIATION 11.75 • n=21 Participants
44.4 years
STANDARD_DEVIATION 13.83 • n=8 Participants
50.7 years
STANDARD_DEVIATION 12.02 • n=8 Participants
51.7 years
STANDARD_DEVIATION 12.13 • n=24 Participants
Sex: Female, Male
Female
30 Participants
n=5 Participants
26 Participants
n=7 Participants
14 Participants
n=5 Participants
12 Participants
n=4 Participants
15 Participants
n=21 Participants
12 Participants
n=8 Participants
18 Participants
n=8 Participants
127 Participants
n=24 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
3 Participants
n=4 Participants
3 Participants
n=21 Participants
1 Participants
n=8 Participants
8 Participants
n=8 Participants
31 Participants
n=24 Participants
Race/Ethnicity, Customized
Caucasian
25 Participants
n=5 Participants
22 Participants
n=7 Participants
13 Participants
n=5 Participants
8 Participants
n=4 Participants
11 Participants
n=21 Participants
5 Participants
n=8 Participants
17 Participants
n=8 Participants
101 Participants
n=24 Participants
Race/Ethnicity, Customized
African
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
2 Participants
n=24 Participants
Race/Ethnicity, Customized
Hispanic
8 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
6 Participants
n=4 Participants
6 Participants
n=21 Participants
5 Participants
n=8 Participants
8 Participants
n=8 Participants
44 Participants
n=24 Participants
Race/Ethnicity, Customized
East Asian
2 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
3 Participants
n=8 Participants
1 Participants
n=8 Participants
10 Participants
n=24 Participants
Race/Ethnicity, Customized
West Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
1 Participants
n=24 Participants
Region of Enrollment
Argentina
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
5 Participants
n=24 Participants
Region of Enrollment
Australia
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
3 Participants
n=24 Participants
Region of Enrollment
Chile
4 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
3 Participants
n=21 Participants
2 Participants
n=8 Participants
2 Participants
n=8 Participants
17 Participants
n=24 Participants
Region of Enrollment
Germany
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
1 Participants
n=24 Participants
Region of Enrollment
Hungary
4 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
2 Participants
n=4 Participants
2 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
14 Participants
n=24 Participants
Region of Enrollment
India
2 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
3 Participants
n=8 Participants
1 Participants
n=8 Participants
10 Participants
n=24 Participants
Region of Enrollment
Mexico
5 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
2 Participants
n=4 Participants
3 Participants
n=21 Participants
3 Participants
n=8 Participants
4 Participants
n=8 Participants
25 Participants
n=24 Participants
Region of Enrollment
Poland
12 Participants
n=5 Participants
8 Participants
n=7 Participants
5 Participants
n=5 Participants
4 Participants
n=4 Participants
4 Participants
n=21 Participants
2 Participants
n=8 Participants
5 Participants
n=8 Participants
40 Participants
n=24 Participants
Region of Enrollment
Romania
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=8 Participants
1 Participants
n=8 Participants
6 Participants
n=24 Participants
Region of Enrollment
Slovakia
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
2 Participants
n=24 Participants
Region of Enrollment
Ukraine
5 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
2 Participants
n=4 Participants
2 Participants
n=21 Participants
0 Participants
n=8 Participants
8 Participants
n=8 Participants
23 Participants
n=24 Participants
Region of Enrollment
United States
1 Participants
n=5 Participants
6 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
2 Participants
n=8 Participants
2 Participants
n=8 Participants
12 Participants
n=24 Participants

PRIMARY outcome

Timeframe: Up to week 24

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). Two participants were excluded due to Good Clinical Practice (GCP) issues.

ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR50 Responder is defined as a participant with \>50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks
18.1 percentage of participants
17.7 percentage of participants
17.0 percentage of participants
15.0 percentage of participants
11.8 percentage of participants
11.8 percentage of participants
37.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF)/non-responder imputation (NRI). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

ACR20 Responder Index is composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR20 Responder is defined as participant with at least 20% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Percentage of Participants Achieving The American College of Rheumatology (ACR)20 Response up to 24 Weeks
43.2 percentage of participants
43.6 percentage of participants
44.3 percentage of participants
46.9 percentage of participants
53.5 percentage of participants
61.5 percentage of participants
70.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

Number of tender and painful joints was determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. Participant was asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy.

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Change From Baseline in the Tender Joint Count up to 24 Weeks
-7.1 tender joints
Standard Deviation 8.21
-7.3 tender joints
Standard Deviation 10.24
-4.5 tender joints
Standard Deviation 7.74
-8.7 tender joints
Standard Deviation 5.94
-7.8 tender joints
Standard Deviation 7.68
-7.4 tender joints
Standard Deviation 10.22
-8.2 tender joints
Standard Deviation 6.41

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

The number of swollen joints was determined by examination of 28 joints which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Change From Baseline in Swollen Joint Count up to 24 Weeks
-5.6 swollen joints
Standard Deviation 5.66
-6.9 swollen joints
Standard Deviation 6.10
-5.7 swollen joints
Standard Deviation 5.57
-8.9 swollen joints
Standard Deviation 6.03
-5.4 swollen joints
Standard Deviation 4.34
-6.2 swollen joints
Standard Deviation 6.19
-7.3 swollen joints
Standard Deviation 5.14

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

DAS (modified to include the 28 joint count \[DAS28\]) consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of his or her disease activity (participant global visual analog scale \[pt global VAS\]). The DAS28 is calculated by using the following formula: DAS28-CRP = 0.56\*sqrt(28TJC) + 0.28\*sqrt(28SJC) + 0.36\*ln(CRP+1) + 0.014\*pt global VAS + 0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity.

Outcome measures

Outcome measures
Measure
Placebo
n=35 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=28 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=19 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=14 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=17 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=12 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=23 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Change From Baseline in the Disease Activity Score (DAS) up to 24 Weeks
-1.448 units on a scale
Standard Deviation 1.310
-1.539 units on a scale
Standard Deviation 1.346
-1.026 units on a scale
Standard Deviation 1.118
-1.678 units on a scale
Standard Deviation 0.987
-1.536 units on a scale
Standard Deviation 1.257
-1.642 units on a scale
Standard Deviation 1.222
-1.915 units on a scale
Standard Deviation 1.183

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

The EULAR28 categorizes clinical response based upon improvement since baseline in the Disease Activity Score (DAS) modified to include the 28 joint count (DAS28) and post-baseline DAS28 level. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (participant global visual analog scale \[VAS\]). EULAR28 categories include: No Response (improvement in DAS28 of less than or equal to 0.6 units or post-baseline DAS28 score greater than 5.1 with improvement by less than or equal to 1.2 units), Moderate Response (post-baseline DAS28 score less than or equal to 5.1 with improvement by more than 0.6 units but no greater than 1.2 units or post-baseline DAS28 score greater than 3.2 with improvement by more than 1.2 units), and Good Response (post-baseline DAS28 score less than or equal to 3.2 with improvement by more than 1.2 units).

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks
Good response
11.4 percentage of participants
10.7 percentage of participants
10.5 percentage of participants
7.1 percentage of participants
23.5 percentage of participants
25.0 percentage of participants
26.1 percentage of participants
Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks
Moderate response
45.7 percentage of participants
53.6 percentage of participants
42.1 percentage of participants
50.0 percentage of participants
52.9 percentage of participants
33.3 percentage of participants
56.5 percentage of participants
Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks
No response
42.9 percentage of participants
35.7 percentage of participants
47.4 percentage of participants
42.9 percentage of participants
23.5 percentage of participants
41.7 percentage of participants
17.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

Participant's assessment of joint pain using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no pain and 100 indicated worst possible pain.

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Change From Baseline in the Participant's Assessment of Joint Pain up to 24 Weeks
-19.5 millimeters (mm)
Standard Deviation 27.50
-17.8 millimeters (mm)
Standard Deviation 23.40
-12.8 millimeters (mm)
Standard Deviation 19.76
-21.2 millimeters (mm)
Standard Deviation 25.42
-13.1 millimeters (mm)
Standard Deviation 21.95
-17.6 millimeters (mm)
Standard Deviation 14.20
-30.3 millimeters (mm)
Standard Deviation 25.93

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

Participant's assessment of disease activity using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.

Outcome measures

Outcome measures
Measure
Placebo
n=35 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=28 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=19 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=17 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Change From Baseline in the Participant's Assessment of Disease Activity up to 24 Weeks
-23.7 millimeters (mm)
Standard Deviation 24.76
-21.2 millimeters (mm)
Standard Deviation 24.63
-16.1 millimeters (mm)
Standard Deviation 18.58
-22.5 millimeters (mm)
Standard Deviation 28.56
-19.3 millimeters (mm)
Standard Deviation 17.58
-15.5 millimeters (mm)
Standard Deviation 19.65
-33.9 millimeters (mm)
Standard Deviation 22.68

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

Physician's assessment of disease activity using a visual analog scale (VAS) that ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Change From Baseline in the Physician's Assessment of Disease Activity up to 24 Weeks
-22.8 millimeters (mm)
Standard Deviation 22.02
-22.8 millimeters (mm)
Standard Deviation 20.26
-26.3 millimeters (mm)
Standard Deviation 26.09
-30.2 millimeters (mm)
Standard Deviation 22.15
-28.3 millimeters (mm)
Standard Deviation 20.62
-21.4 millimeters (mm)
Standard Deviation 15.96
-36.1 millimeters (mm)
Standard Deviation 17.06

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

Participant's assessment of physical function. Disability section of questionnaire scores participant's self-perception on 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, reach, grip, and performing other daily activities. Scores for each of the functional areas were averaged to calculate the functional disability index. The HAQ-DI total score, which is the average of the nonmissing functional scores, ranges from 0 (no disability) to 3 (severe disability).

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) up to 24 Weeks
-0.281 units on a scale
Standard Deviation 0.481
-0.288 units on a scale
Standard Deviation 0.609
-0.206 units on a scale
Standard Deviation 0.406
-0.258 units on a scale
Standard Deviation 0.373
-0.292 units on a scale
Standard Deviation 0.554
-0.587 units on a scale
Standard Deviation 0.546
-0.370 units on a scale
Standard Deviation 0.426

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

Percent change = \[(postbaseline CRP - baseline CRP)/baseline CRP\]\*100.

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Percent Change From Baseline in C-Reactive Protein (CRP) up to 24 Weeks
9.13 percent change
Standard Deviation 136.683
18.28 percent change
Standard Deviation 92.909
93.75 percent change
Standard Deviation 265.331
5.60 percent change
Standard Deviation 73.212
24.17 percent change
Standard Deviation 188.146
-34.42 percent change
Standard Deviation 46.632
7.50 percent change
Standard Deviation 132.313

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

The FACIT Fatigue Scale is a brief participant-reported measure of fatigue and consists of 13 items. Scores range from 0 to 52, with higher scores indicating less fatigue.

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Change From Baseline in the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale up to 24 Weeks
4.4 units on a scale
Standard Deviation 12.22
3.9 units on a scale
Standard Deviation 10.95
3.8 units on a scale
Standard Deviation 8.04
8.1 units on a scale
Standard Deviation 8.77
6.9 units on a scale
Standard Deviation 8.08
8.0 units on a scale
Standard Deviation 8.19
9.6 units on a scale
Standard Deviation 7.83

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains. MCS and PCS scores = 0 to 100 (higher scores indicate better health status).

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=17 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Change From Baseline in the Short Form Health Survey (SF-36) up to 24 Weeks
Physical Health Component
4.284 units on a scale
Standard Deviation 7.889
3.422 units on a scale
Standard Deviation 7.592
2.534 units on a scale
Standard Deviation 4.779
5.584 units on a scale
Standard Deviation 7.905
3.680 units on a scale
Standard Deviation 5.289
9.487 units on a scale
Standard Deviation 8.366
4.053 units on a scale
Standard Deviation 6.353
Change From Baseline in the Short Form Health Survey (SF-36) up to 24 Weeks
Mental Health Component
3.623 units on a scale
Standard Deviation 10.414
2.899 units on a scale
Standard Deviation 13.094
4.263 units on a scale
Standard Deviation 11.304
5.223 units on a scale
Standard Deviation 11.289
4.166 units on a scale
Standard Deviation 7.733
6.266 units on a scale
Standard Deviation 7.139
9.198 units on a scale
Standard Deviation 9.822

SECONDARY outcome

Timeframe: 24 weeks

Population: The PK analysis population included all intent-to-treat (ITT) participants who received LY2127399 and who had evaluable PK data except 2 participants who were excluded due to Good Clinical Practice (GCP) issues.

C-trough is defined as the concentration of LY2127399 at the end of the dosing interval after the subcutaneous (sc) injection dosing once every 4 weeks. Mean C-trough value was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.

Outcome measures

Outcome measures
Measure
Placebo
n=30 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Pharmacokinetics of LY2127399: C-Trough Steady State Concentration at 24 Weeks
0.0100 micrograms per milliliter (µg/mL)
0.0400 micrograms per milliliter (µg/mL)
0.270 micrograms per milliliter (µg/mL)
1.94 micrograms per milliliter (µg/mL)
5.16 micrograms per milliliter (µg/mL)
11.9 micrograms per milliliter (µg/mL)
—

SECONDARY outcome

Timeframe: 24 weeks

Population: The PK analysis population included all intent-to-treat (ITT) participants who received LY2127399 and who had evaluable PK data except 2 participants who were excluded due to Good Clinical Practice (GCP) issues.

T1/2,tau is defined as the apparent steady state elimination within the dosing interval. T1/2,tau was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.

Outcome measures

Outcome measures
Measure
Placebo
n=30 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Pharmacokinetics of LY2127399: T-Half Life (t1/2, Tau) at 24 Weeks
7.07 days
7.94 days
9.76 days
15.9 days
19.5 days
21.6 days
—

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. Total B cell counts (CD20+CD3-) are represented by the number of cells per microliter (cells/µL). The reference range is 43 - 602 cells/µL.

Outcome measures

Outcome measures
Measure
Placebo
n=35 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=17 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Change From Baseline in the Absolute Total B Cell (CD20+CD3- Cells) Count up to 24 Weeks
17.63 cells per microliter (cells/µL)
Standard Deviation 75.880
-18.77 cells per microliter (cells/µL)
Standard Deviation 96.410
-50.85 cells per microliter (cells/µL)
Standard Deviation 130.405
-36.87 cells per microliter (cells/µL)
Standard Deviation 71.287
-68.59 cells per microliter (cells/µL)
Standard Deviation 115.971
-11.15 cells per microliter (cells/µL)
Standard Deviation 111.577
-27.88 cells per microliter (cells/µL)
Standard Deviation 97.729

SECONDARY outcome

Timeframe: Baseline, up to 24 weeks

Population: Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.

Serum immunoglobulin measured by Immunoglobulin G (IgG), Immunoglobulin M (IgM), and Immunoglobulin A (IgA) levels.

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=24 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Change From Baseline in Serum Immunoglobulin up to 24 Weeks
IgG
-0.12 gram per liter (g/L)
Standard Deviation 2.964
-0.14 gram per liter (g/L)
Standard Deviation 1.986
-0.45 gram per liter (g/L)
Standard Deviation 3.179
-0.45 gram per liter (g/L)
Standard Deviation 2.303
-1.06 gram per liter (g/L)
Standard Deviation 2.650
-0.93 gram per liter (g/L)
Standard Deviation 1.381
-0.37 gram per liter (g/L)
Standard Deviation 2.147
Change From Baseline in Serum Immunoglobulin up to 24 Weeks
IgM
0.02 gram per liter (g/L)
Standard Deviation 0.323
0.07 gram per liter (g/L)
Standard Deviation 0.336
-0.02 gram per liter (g/L)
Standard Deviation 0.269
-0.11 gram per liter (g/L)
Standard Deviation 0.283
-0.08 gram per liter (g/L)
Standard Deviation 0.531
-0.30 gram per liter (g/L)
Standard Deviation 0.299
-0.09 gram per liter (g/L)
Standard Deviation 0.384
Change From Baseline in Serum Immunoglobulin up to 24 Weeks
IgA
-0.12 gram per liter (g/L)
Standard Deviation 0.482
-0.09 gram per liter (g/L)
Standard Deviation 0.583
-0.24 gram per liter (g/L)
Standard Deviation 0.712
-0.53 gram per liter (g/L)
Standard Deviation 0.679
-0.58 gram per liter (g/L)
Standard Deviation 0.977
-0.42 gram per liter (g/L)
Standard Deviation 0.453
-0.25 gram per liter (g/L)
Standard Deviation 0.631

SECONDARY outcome

Timeframe: Baseline up to 24 weeks

Population: All randomized participants who received any amount of blinded study drug.

Serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.

Outcome measures

Outcome measures
Measure
Placebo
n=36 Participants
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
1 mg LY2127399
n=30 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
3 mg LY2127399
n=20 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
10 mg LY2127399
n=15 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
30 mg LY2127399
n=18 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
60 mg LY2127399
n=13 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
120 mg LY2127399
n=26 Participants
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Number of Participants Experiencing An Adverse Event
Other Nonserious Adverse Events
21 Participants
19 Participants
12 Participants
9 Participants
11 Participants
8 Participants
13 Participants
Number of Participants Experiencing An Adverse Event
Serious Adverse Events
5 Participants
4 Participants
0 Participants
0 Participants
3 Participants
2 Participants
1 Participants

Adverse Events

Placebo

Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths

1 mg LY2127399

Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths

3 mg LY2127399

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

10 mg LY2127399

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

30 mg LY2127399

Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths

60 mg LY2127399

Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths

120 mg LY2127399

Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths

Placebo - Follow-up Period

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

1 mg LY2127399 - Follow-up Period

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

3 mg LY2127399 - Follow-up Period

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

10 mg LY2127399 - Follow-up Period

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

30 mg LY2127399 - Follow-up Period

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

60 mg LY2127399 - Follow-up Period

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

120 mg LY2127399 - Follow-up Period

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo
n=36 participants at risk
Placebo was administered subcutaneously (SC) every 4 weeks over a 24-week period.
1 mg LY2127399
n=30 participants at risk
1 milligram (mg) of LY2127399 was administered SC every 4 weeks over a 24-week period.
3 mg LY2127399
n=20 participants at risk
3 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10 mg LY2127399
n=15 participants at risk
10 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
30 mg LY2127399
n=18 participants at risk
30 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
60 mg LY2127399
n=13 participants at risk
60 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
120 mg LY2127399
n=26 participants at risk
120 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
Placebo - Follow-up Period
n=8 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
1 mg LY2127399 - Follow-up Period
n=8 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
3 mg LY2127399 - Follow-up Period
n=6 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
10 mg LY2127399 - Follow-up Period
n=4 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
30 mg LY2127399 - Follow-up Period
n=6 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
60 mg LY2127399 - Follow-up Period
Participants were assessed but did not receive any study medication during the follow-up period.
120 mg LY2127399 - Follow-up Period
n=14 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
Cardiac disorders
Atrial flutter
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Colitis
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
General disorders
Asthenia
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
General disorders
Chest pain
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Hepatobiliary disorders
Bile duct stone
2.8%
1/36 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Diverticulitis
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Lung infection
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Pneumonia influenzal
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Pyelonephritis
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
16.7%
1/6 • Number of events 1
—
0/0
0.00%
0/14
Infections and infestations
Sepsis
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
16.7%
1/6 • Number of events 1
—
0/0
0.00%
0/14
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
5.6%
2/36 • Number of events 2
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
16.7%
1/6 • Number of events 1
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Nervous system disorders
Dizziness
0.00%
0/36
3.3%
1/30 • Number of events 2
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Nervous system disorders
Hemiplegia
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Renal and urinary disorders
Nephrolithiasis
2.8%
1/36 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Renal and urinary disorders
Renal failure
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Reproductive system and breast disorders
Ovarian cyst
2.8%
1/36 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Reproductive system and breast disorders
Postmenopausal haemorrhage
2.8%
1/36 • Number of events 2
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14

Other adverse events

Other adverse events
Measure
Placebo
n=36 participants at risk
Placebo was administered subcutaneously (SC) every 4 weeks over a 24-week period.
1 mg LY2127399
n=30 participants at risk
1 milligram (mg) of LY2127399 was administered SC every 4 weeks over a 24-week period.
3 mg LY2127399
n=20 participants at risk
3 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
10 mg LY2127399
n=15 participants at risk
10 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
30 mg LY2127399
n=18 participants at risk
30 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
60 mg LY2127399
n=13 participants at risk
60 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
120 mg LY2127399
n=26 participants at risk
120 mg of LY2127399 was administered SC every 4 weeks over a 24-week period.
Placebo - Follow-up Period
n=8 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
1 mg LY2127399 - Follow-up Period
n=8 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
3 mg LY2127399 - Follow-up Period
n=6 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
10 mg LY2127399 - Follow-up Period
n=4 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
30 mg LY2127399 - Follow-up Period
n=6 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
60 mg LY2127399 - Follow-up Period
Participants were assessed but did not receive any study medication during the follow-up period.
120 mg LY2127399 - Follow-up Period
n=14 participants at risk
Participants were assessed but did not receive any study medication during the follow-up period.
Investigations
Neutrophil count increased
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Platelet count increased
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Red blood cell sedimentation rate increased
2.8%
1/36 • Number of events 1
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Transaminases increased
2.8%
1/36 • Number of events 1
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Blood and lymphatic system disorders
Anaemia
0.00%
0/36
3.3%
1/30 • Number of events 1
10.0%
2/20 • Number of events 2
6.7%
1/15 • Number of events 1
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
16.7%
1/6 • Number of events 1
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Blood and lymphatic system disorders
Eosinophilia
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Blood and lymphatic system disorders
Leukopenia
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
16.7%
1/6 • Number of events 1
—
0/0
0.00%
0/14
Blood and lymphatic system disorders
Microcytic anaemia
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Blood and lymphatic system disorders
Thrombocytosis
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Cardiac disorders
Bradycardia
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Cardiac disorders
Myocardial ischaemia
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Cardiac disorders
Sinus bradycardia
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Ear and labyrinth disorders
Deafness
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
16.7%
1/6 • Number of events 1
—
0/0
0.00%
0/14
Ear and labyrinth disorders
Vertigo
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Eye disorders
Foreign body sensation in eyes
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Eye disorders
Lacrimation increased
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Abdominal distension
2.8%
1/36 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
25.0%
1/4 • Number of events 1
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
16.7%
1/6 • Number of events 1
—
0/0
0.00%
0/14
Gastrointestinal disorders
Constipation
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Diarrhoea
5.6%
2/36 • Number of events 2
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Flatulence
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Food poisoning
2.8%
1/36 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Gastritis
2.8%
1/36 • Number of events 1
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Nausea
2.8%
1/36 • Number of events 1
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
7.1%
1/14 • Number of events 2
Gastrointestinal disorders
Periodontitis
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
12.5%
1/8 • Number of events 1
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Gastrointestinal disorders
Toothache
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
General disorders
Chills
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
General disorders
Fatigue
2.8%
1/36 • Number of events 1
3.3%
1/30 • Number of events 1
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
General disorders
Injection site erythema
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
General disorders
Injection site pain
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
26.7%
4/15 • Number of events 4
5.6%
1/18 • Number of events 1
7.7%
1/13 • Number of events 1
7.7%
2/26 • Number of events 2
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
General disorders
Injection site pruritus
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
General disorders
Non-cardiac chest pain
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
General disorders
Oedema
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
General disorders
Pyrexia
2.8%
1/36 • Number of events 1
6.7%
2/30 • Number of events 2
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Hepatobiliary disorders
Hepatotoxicity
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Immune system disorders
Allergy to arthropod bite
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Abscess neck
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
16.7%
1/6 • Number of events 1
—
0/0
0.00%
0/14
Infections and infestations
Acute sinusitis
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
12.5%
1/8 • Number of events 1
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Bronchitis
0.00%
0/36
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
15.4%
2/13 • Number of events 2
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Cellulitis
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Diverticulitis
0.00%
0/36
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Furuncle
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Gastroenteritis
2.8%
1/36 • Number of events 1
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Gastroenteritis viral
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Gingival abscess
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
H1n1 influenza
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Herpes zoster
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Impetigo
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Influenza
0.00%
0/36
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Laryngitis viral
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Nasopharyngitis
5.6%
2/36 • Number of events 2
6.7%
2/30 • Number of events 2
0.00%
0/20
0.00%
0/15
11.1%
2/18 • Number of events 2
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Oral fungal infection
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Oral herpes
2.8%
1/36 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
25.0%
1/4 • Number of events 1
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Pharyngitis
0.00%
0/36
0.00%
0/30
5.0%
1/20 • Number of events 1
6.7%
1/15 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Respiratory tract infection
0.00%
0/36
3.3%
1/30 • Number of events 1
10.0%
2/20 • Number of events 2
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Tinea versicolour
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Trichophytic granuloma
0.00%
0/36
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Upper respiratory tract infection
2.8%
1/36 • Number of events 1
10.0%
3/30 • Number of events 3
0.00%
0/20
20.0%
3/15 • Number of events 3
0.00%
0/18
15.4%
2/13 • Number of events 2
3.8%
1/26 • Number of events 1
0.00%
0/8
12.5%
1/8 • Number of events 1
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Urinary tract infection
2.8%
1/36 • Number of events 1
3.3%
1/30 • Number of events 1
10.0%
2/20 • Number of events 2
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
25.0%
1/4 • Number of events 1
0.00%
0/6
—
0/0
0.00%
0/14
Injury, poisoning and procedural complications
Contusion
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
12.5%
1/8 • Number of events 1
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Injury, poisoning and procedural complications
Fall
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Injury, poisoning and procedural complications
Joint injury
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Injury, poisoning and procedural complications
Joint sprain
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Injury, poisoning and procedural complications
Traumatic haematoma
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Alanine aminotransferase increased
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Aspartate aminotransferase increased
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Blood alkaline phosphatase increased
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Body temperature increased
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Electrocardiogram qt interval abnormal
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Electrocardiogram qt prolonged
0.00%
0/36
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Electrocardiogram t wave abnormal
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Gamma-glutamyltransferase increased
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Hepatic enzyme increased
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
12.5%
1/8 • Number of events 1
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Weight decreased
0.00%
0/36
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
Weight increased
0.00%
0/36
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
0.00%
0/15
5.6%
1/18 • Number of events 1
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Investigations
White blood cell count increased
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Metabolism and nutrition disorders
Diabetes mellitus
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/36
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/36
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
13.9%
5/36 • Number of events 5
10.0%
3/30 • Number of events 5
10.0%
2/20 • Number of events 2
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 2
0.00%
0/8
0.00%
0/8
0.00%
0/6
25.0%
1/4 • Number of events 1
0.00%
0/6
—
0/0
0.00%
0/14
Nervous system disorders
Diabetic neuropathy
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Nervous system disorders
Headache
5.6%
2/36 • Number of events 2
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Nervous system disorders
Hypoaesthesia
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Nervous system disorders
Intercostal neuralgia
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Nervous system disorders
Neuralgia
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Nervous system disorders
Paraesthesia
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 2
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Nervous system disorders
Somnolence
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 2
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Nervous system disorders
Trigeminal neuralgia
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
12.5%
1/8 • Number of events 1
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Psychiatric disorders
Depression
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Psychiatric disorders
Insomnia
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Reproductive system and breast disorders
Erectile dysfunction
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Reproductive system and breast disorders
Menorrhagia
0.00%
0/36
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Reproductive system and breast disorders
Postmenopausal haemorrhage
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
7.7%
1/13 • Number of events 1
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Respiratory, thoracic and mediastinal disorders
Cough
2.8%
1/36 • Number of events 1
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
6.7%
1/15 • Number of events 2
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/36
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/36
3.3%
1/30 • Number of events 1
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Skin and subcutaneous tissue disorders
Dyshidrosis
0.00%
0/36
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Skin and subcutaneous tissue disorders
Hyperhidrosis
2.8%
1/36 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Skin and subcutaneous tissue disorders
Rash
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
5.6%
1/18 • Number of events 2
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Skin and subcutaneous tissue disorders
Skin plaque
0.00%
0/36
0.00%
0/30
0.00%
0/20
6.7%
1/15 • Number of events 1
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Skin and subcutaneous tissue disorders
Stasis dermatitis
0.00%
0/36
0.00%
0/30
0.00%
0/20
0.00%
0/15
0.00%
0/18
0.00%
0/13
3.8%
1/26 • Number of events 1
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Surgical and medical procedures
Cervical diathermy
0.00%
0/36
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/15
0.00%
0/18
0.00%
0/13
0.00%
0/26
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14
Vascular disorders
Hypertension
0.00%
0/36
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
0.00%
0/15
5.6%
1/18 • Number of events 1
0.00%
0/13
7.7%
2/26 • Number of events 2
0.00%
0/8
0.00%
0/8
0.00%
0/6
0.00%
0/4
0.00%
0/6
—
0/0
0.00%
0/14

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