Trial Outcomes & Findings for A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy (NCT NCT00689728)

Last Updated: 2018-12-06

Results Overview

ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR50 Responder is defined as a participant with greater than 50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient 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

100 participants

Primary outcome timeframe

16 weeks

Results posted on

2018-12-06

Participant Flow

Double-blind treatment was administered at Weeks 0, 3, and 6. At Week 16, participants not having at least a 20% decrease in tender or swollen joint counts could receive rescue therapy. Post-study B-cell follow-up (safety only) occurred beyond Week 24.

Participant milestones

Participant milestones
Measure	30 mg LY2127399 Double-blind: 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: either remain on 30 mg LY2127399 or receive 80 mg LY2127399 up to Week 24. Optional Follow-up: assessing safety after Week 24, if needed.	80 mg LY2127399 Double-blind: 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: remain on 80 mg LY2127399 up to Week 24. Optional Follow-up: assessing safety after Week 24, if needed.	Placebo Double-blind: Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: either remain on placebo or receive 80 mg LY2127399 up to Week 24. Optional Follow-up: assessing safety after Week 24, if needed.
Double-Blind Treatment STARTED	35	30	35
Double-Blind Treatment COMPLETED	31	26	30
Double-Blind Treatment NOT COMPLETED	4	4	5
Rescue STARTED	31	26	30
Rescue COMPLETED	30	24	29
Rescue NOT COMPLETED	1	2	1
Optional Follow-Up STARTED	9	11	10
Optional Follow-Up COMPLETED	6	5	4
Optional Follow-Up NOT COMPLETED	3	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	30 mg LY2127399 Double-blind: 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: either remain on 30 mg LY2127399 or receive 80 mg LY2127399 up to Week 24. Optional Follow-up: assessing safety after Week 24, if needed.	80 mg LY2127399 Double-blind: 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: remain on 80 mg LY2127399 up to Week 24. Optional Follow-up: assessing safety after Week 24, if needed.	Placebo Double-blind: Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: either remain on placebo or receive 80 mg LY2127399 up to Week 24. Optional Follow-up: assessing safety after Week 24, if needed.
Double-Blind Treatment Adverse Event	1	0	0
Double-Blind Treatment Protocol Violation	0	0	1
Double-Blind Treatment Withdrawal by Subject	3	3	2
Double-Blind Treatment Lack of Efficacy	0	1	2
Rescue Adverse Event	0	1	0
Rescue Withdrawal by Subject	1	1	1
Optional Follow-Up Adverse Event	1	0	0
Optional Follow-Up Lack of Efficacy	0	1	1
Optional Follow-Up Lost to Follow-up	0	1	1
Optional Follow-Up Protocol Violation	0	0	1
Optional Follow-Up Withdrawal by Subject	2	4	3

Baseline Characteristics

A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=30 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Total n=100 Participants Total of all reporting groups
Age, Continuous	52.4 Years STANDARD_DEVIATION 13.03 • n=5 Participants	52.7 Years STANDARD_DEVIATION 14.05 • n=7 Participants	52.2 Years STANDARD_DEVIATION 11.46 • n=5 Participants	52.4 Years STANDARD_DEVIATION 12.70 • n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	26 Participants n=7 Participants	32 Participants n=5 Participants	86 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	26 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	67 Participants n=4 Participants
Race/Ethnicity, Customized African	3 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	14 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Region of Enrollment United States	18 Participants n=5 Participants	18 Participants n=7 Participants	14 Participants n=5 Participants	50 Participants n=4 Participants
Region of Enrollment Puerto Rico	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Canada	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment Argentina	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment Poland	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment Belgium	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Brazil	6 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment Austria	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment Germany	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Non-responder imputation/last observation carried forward (NRI/LOCF); intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline ACR50 assessment. Two participants from sites with good clinical practice \[GCP\] violations are excluded.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=28 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16	11.4 Percentage of Participants	14.3 Percentage of Participants	2.9 Percentage of Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 68 weeks

Population: Safety population defined as all participants who were randomized and received at least one dose of study drug.

Serious adverse events and other non-serious adverse events are located in the Reported Adverse Event section.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=30 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment n=19 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment n=12 Participants Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment n=15 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment n=11 Participants Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment n=10 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment n=20 Participants Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up n=9 Participants Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up n=11 Participants Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up n=10 Participants Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Number of Participants Experiencing An Adverse Event Serious	1 Participants	2 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Experiencing An Adverse Event Other	22 Participants	21 Participants	22 Participants	2 Participants	5 Participants	6 Participants	3 Participants	3 Participants	11 Participants	1 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline SF-36 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

Self-reported questionnaire of 36 questions in 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health). Each domain is scored by summing individual items and transforming scores into a 0-100 scale (higher scores=better health status/function). The mental and physical component summaries are based on the 8 domains. Component scores are transformed scores representing a mean (50) and standard deviation (10) in the general United States (US) population. Scores \> or \<50 are above or below the average US population.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=34 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=27 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=34 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16 Physical Health	5.064 Units on a Scale Standard Deviation 8.73	5.197 Units on a Scale Standard Deviation 8.36	1.229 Units on a Scale Standard Deviation 6.18	—	—	—	—	—	—	—	—	—
Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16 Mental Health	2.700 Units on a Scale Standard Deviation 10.82	3.597 Units on a Scale Standard Deviation 11.96	0.133 Units on a Scale Standard Deviation 12.99	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 16 weeks

Population: Non-responder imputation (NRI)/last observation carried forward; intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline ACR20 assessment. Two participants from sites with good clinical practice \[GCP\] violations are excluded.

ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR20 Responder is defined as a 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, patient 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	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=28 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16	25.7 Percentage of Participants	28.6 Percentage of Participants	17.1 Percentage of Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 16 weeks

Population: Non-responder imputation (NRI)/last observation carried forward; intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline ACR70 assessment. Two participants from sites with good clinical practice \[GCP\] violations are excluded.

ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR70 Responder is defined as a participant with at least 70% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient 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	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=28 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Percentage of Participants Achieving American College of Rheumatology (ACR)70 Response at Week 16	2.9 Percentage of Participants	3.6 Percentage of Participants	0 Percentage of Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline tender joint assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

The number of tender and painful joints is 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. The joints are assessed and classified as tender or not tender.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=28 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Change From Baseline in Tender Joint Count at Week 16	-4.5 Tender Joints Standard Deviation 6.74	-6.3 Tender Joints Standard Deviation 4.96	-3.3 Tender Joints Standard Deviation 8.20	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline swollen joint assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

The number of swollen joints is 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. The joints are assessed and classified as swollen or not swollen.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=28 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Change From Baseline in Swollen Joint Count at Week 16	-2.6 Swollen Joints Standard Deviation 5.23	-4.7 Swollen Joints Standard Deviation 4.44	-2.3 Swollen Joints Standard Deviation 5.54	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline joint pain assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

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

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=28 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Change From Baseline in Participant's Assessment of Joint Pain at Week 16	-16.1 Millimeters Standard Deviation 26.86	-17.8 Millimeters Standard Deviation 27.10	-9.1 Millimeters Standard Deviation 29.20	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline disease activity assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

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

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=26 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Change From Baseline in Participant's Assessment of Disease Activity at Week 16	-20.2 Millimeters Standard Deviation 25.87	-23.6 Millimeters Standard Deviation 29.36	-11.2 Millimeters Standard Deviation 29.05	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline physician's disease activity assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

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

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=27 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16	-17.7 Millimeters Standard Deviation 22.55	-17.3 Millimeters Standard Deviation 29.67	-13.1 Millimeters Standard Deviation 26.40	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline HAQ-DI assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

The HAQ-DI questionnaire scores the participant's self-perception on the degree of difficulty when dressing and grooming, arising, eating, walking, hygiene, reach, grip, and performing other daily activities (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do). The scores for each of the functional areas, which have a range from 0 to 3, are averaged to calculate the functional disability index. Higher scores are associated with greater disability.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=28 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16	-0.161 Units on a Scale Standard Deviation 0.569	-0.259 Units on a Scale Standard Deviation 0.623	-0.205 Units on a Scale Standard Deviation 0.511	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline CRP assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=27 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Percent Change From Baseline in C-reactive Protein (CRP) at Week 16	58.88 Percent Change Standard Deviation 216.005	15.14 Percent Change Standard Deviation 123.625	71.64 Percent Change Standard Deviation 410.942	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline DAS28 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

Disease Activity Score (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 their disease activity (patient global VAS). It is calculated by using the following formula:DAS28-CRP=0.56 times the square root of(28TJC)+0.28 times the square root of(28SJC)+0.36\*natural log (ln)(CRP+1)+0.014\*patient global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=26 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=34 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Change From Baseline in Disease Activity Score (DAS28) at Week 16	-0.911 Units on a Scale Standard Deviation 1.137	-1.288 Units on a Scale Standard Deviation 0.934	-0.613 Units on a Scale Standard Deviation 1.041	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline EULAR28 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

EULAR28 categorizes clinical response based upon improvement since baseline in Disease Activity Score modified to include the 28 joint count (DAS28) and post-baseline DAS28. 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 (patient global 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	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=26 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=34 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16 Moderate response	8 Participants	12 Participants	15 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16 Good response	5 Participants	5 Participants	0 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16 No response	22 Participants	9 Participants	19 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline FACIT assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

The FACIT Fatigue Score is a brief patient-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	30 mg LY2127399 n=34 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=27 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=34 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 16	2.5 Units on a Scale Standard Deviation 11.20	7.9 Units on a Scale Standard Deviation 8.44	3.1 Units on a Scale Standard Deviation 9.56	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline CD20 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. For this endpoint, total B cell counts (CD20+CD3- cells) are represented by number of cells per microliter. The reference range for the absolute counts is 43-602 cells per microliter.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=32 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=26 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=33 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Pharmacodynamics: Change From Baseline in Absolute CD20 + B Cell Count at Week 16	-30.94 Cells per Microliter Standard Deviation 152.813	-34.92 Cells per Microliter Standard Deviation 82.090	0.79 Cells per Microliter Standard Deviation 144.251	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. For this outcome, total B cells (CD20+CD3- cells) are expressed as the relative percent of lymphocytes. There is no reference range provided for this parameter by the performing laboratory.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=32 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=26 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=33 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Pharmacodynamics: Change From Baseline in Total B Cells (CD20 + CD3-) as a Percentage of Total Lymphocytes	-2.26 Percentage of Lymphocytes Standard Deviation 4.651	-2.20 Percentage of Lymphocytes Standard Deviation 4.517	-0.59 Percentage of Lymphocytes Standard Deviation 4.856	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline serum immunoglobulin assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice \[GCP\] violations are excluded.

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

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=34 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=28 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo n=35 Participants Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16 Immunoglobulin M	-0.27 gram/Liter Standard Deviation 0.325	-0.24 gram/Liter Standard Deviation 0.371	-0.05 gram/Liter Standard Deviation 0.388	—	—	—	—	—	—	—	—	—
Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16 Immunoglobulin G	-0.83 gram/Liter Standard Deviation 1.233	-1.33 gram/Liter Standard Deviation 2.055	-0.62 gram/Liter Standard Deviation 1.783	—	—	—	—	—	—	—	—	—
Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16 Immunoglobulin A	-0.24 gram/Liter Standard Deviation 0.429	-0.26 gram/Liter Standard Deviation 0.405	-0.23 gram/Liter Standard Deviation 0.729	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, Day 1 through Week 24

Population: All randomized participants with evaluable PK C-trough data.

C-trough is defined as the concentration of LY at the end of the dosing interval at steady state. Mean C-trough value was obtained by conducting a simulation consisting of 1000 participants. The simulated data were then used to determine the noncompartmental PK parameters for each regimen. Mean and standard deviation of the Ctrough values were calculated for each dose group based on simulated data.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=28 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Pharmacokinetics: Predicted Population Mean Parameter: C-trough Steady-state	5.84 Micrograms per Milliliter Standard Deviation 2.87	18.9 Micrograms per Milliliter Standard Deviation 7.86	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, Day 1 through Week 24

Population: All randomized participants with evaluable PK t-half life data.

T-half life (t1/2, tau) is defined as the apparent steady state elimination within the dosing interval. T-half life was obtained by conducting a simulation consisting of 1000 participants using the study drug regimens (30 and 80 mg, intravenous infusion over 30 minutes, once every 3 weeks). The simulated data were then used to determine the noncompartmental PK parameters for each regimen. Mean and standard deviation of the t-half life values were calculated for each dose group based on simulated data.

Outcome measures

Outcome measures
Measure	30 mg LY2127399 n=35 Participants 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 n=28 Participants 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 30 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Without Rescue Treatment 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment Participants who were randomized to LY2127399 80 mg during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Without Rescue Treatment Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	30 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 30 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	80 mg LY2127399 - Follow Up Participants who were randomized to LY2127399 80 mg during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.	Placebo - Follow Up Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of LY2127399 80 mg at Week 16.
Pharmacokinetics: Predicted Population Mean Parameter: T-half Life (t1/2, Tau)	19 Days Standard Deviation 8	22 Days Standard Deviation 8	—	—	—	—	—	—	—	—	—	—

Adverse Events

30 mg LY2127399 - Treatment

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

80 mg LY2127399 - Treatment

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo - Treatment

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

30 mg LY2127399 - Without Rescue Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

30 mg LY2127399 - With Rescue Treatment

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

80 mg LY2127399 - Without Rescue Treatment

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

80 mg LY2127399 - With Rescue Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo - Without Rescue Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo - With Rescue Treatment

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

30 mg LY2127399 - Follow-up

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

80 mg LY2127399 - Follow-up

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo - Follow-up

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	30 mg LY2127399 - Treatment n=35 participants at risk 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - Treatment n=30 participants at risk 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - Treatment n=35 participants at risk Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment n=19 participants at risk 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment n=12 participants at risk Participants who were randomized to 30 mg LY2127399 during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.	80 mg LY2127399 - Without Rescue Treatment n=15 participants at risk 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment n=11 participants at risk Participants who were randomized to 80 mg LY2127399 during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.	Placebo - Without Rescue Treatment n=10 participants at risk Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment n=20 participants at risk Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.	30 mg LY2127399 - Follow-up n=9 participants at risk Participants who were randomized to 30 mg LY2127399 during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.	80 mg LY2127399 - Follow-up n=11 participants at risk Participants who were randomized to 80 mg LY2127399 during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.	Placebo - Follow-up n=10 participants at risk Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.
Gastrointestinal disorders Constipation	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Gastrointestinal disorders Crohn's disease	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Gastroenteritis	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Rhinitis	2.9% 1/35 • Number of events 1	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Tracheitis	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Injury, poisoning and procedural complications Back injury	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Injury, poisoning and procedural complications Chest injury	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Injury, poisoning and procedural complications Heart injury	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/35	3.3% 1/30 • Number of events 1	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Nervous system disorders Dizziness	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Hyperkeratosis	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10

Other adverse events

Other adverse events
Measure	30 mg LY2127399 - Treatment n=35 participants at risk 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - Treatment n=30 participants at risk 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - Treatment n=35 participants at risk Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - Without Rescue Treatment n=19 participants at risk 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	30 mg LY2127399 - With Rescue Treatment n=12 participants at risk Participants who were randomized to 30 mg LY2127399 during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.	80 mg LY2127399 - Without Rescue Treatment n=15 participants at risk 80 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	80 mg LY2127399 - With Rescue Treatment n=11 participants at risk Participants who were randomized to 80 mg LY2127399 during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.	Placebo - Without Rescue Treatment n=10 participants at risk Placebo comparator administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.	Placebo - With Rescue Treatment n=20 participants at risk Participants who were randomized to placebo during Treatment Phase who did not have an improvement of at least 20% in either their tender or their swollen joint counts, based on 28 joints at Week 16 assessments and chose to receive optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.	30 mg LY2127399 - Follow-up n=9 participants at risk Participants who were randomized to 30 mg LY2127399 during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.	80 mg LY2127399 - Follow-up n=11 participants at risk Participants who were randomized to 80 mg LY2127399 during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.	Placebo - Follow-up n=10 participants at risk Participants who were randomized to placebo during Treatment Phase who required additional follow-up for monitoring of their B cell counts, regardless of whether or not they received optional rescue treatment of an additional 30 minute infusion of 80 mg LY2127399 at Week 16.
Blood and lymphatic system disorders Anaemia	0.00% 0/35	10.0% 3/30 • Number of events 3	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	9.1% 1/11 • Number of events 1	0.00% 0/10
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Cardiac disorders Arrhythmia	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Cardiac disorders Palpitations	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Endocrine disorders Hypothyroidism	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	11.1% 1/9 • Number of events 1	0.00% 0/11	0.00% 0/10
Eye disorders Eye pain	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Eye disorders Photophobia	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Eye disorders Vision blurred	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Gastrointestinal disorders Abdominal pain lower	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Gastrointestinal disorders Abdominal pain upper	5.7% 2/35 • Number of events 2	6.7% 2/30 • Number of events 2	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Gastrointestinal disorders Diarrhoea	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	6.7% 1/15 • Number of events 1	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Gastrointestinal disorders Haemorrhoids	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Gastrointestinal disorders Hiatus hernia	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Gastrointestinal disorders Mouth ulceration	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Gastrointestinal disorders Nausea	0.00% 0/35	6.7% 2/30 • Number of events 2	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Gastrointestinal disorders Odynophagia	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	10.0% 1/10 • Number of events 1
Gastrointestinal disorders Vomiting	0.00% 0/35	3.3% 1/30 • Number of events 1	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	9.1% 1/11 • Number of events 1	0.00% 0/10
General disorders Chest pain	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
General disorders Fatigue	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
General disorders Generalised oedema	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
General disorders Infusion site phlebitis	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
General disorders Non-cardiac chest pain	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
General disorders Oedema peripheral	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
General disorders Pyrexia	5.7% 2/35 • Number of events 2	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Hepatobiliary disorders Hepatic cyst	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Hepatobiliary disorders Hepatic mass	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Immune system disorders Drug hypersensitivity	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Bronchitis	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	5.3% 1/19 • Number of events 1	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Cellulitis	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	10.0% 1/10 • Number of events 1	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Cellulitis of male external genital organ	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Ear infection	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	10.0% 1/10 • Number of events 1	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Gastroenteritis	2.9% 1/35 • Number of events 1	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Gastroenteritis viral	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Granuloma inguinale	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Influenza	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Nasopharyngitis	8.6% 3/35 • Number of events 3	0.00% 0/30	5.7% 2/35 • Number of events 2	0.00% 0/19	0.00% 0/12	0.00% 0/15	9.1% 1/11 • Number of events 1	0.00% 0/10	0.00% 0/20	0.00% 0/9	9.1% 1/11 • Number of events 1	0.00% 0/10
Infections and infestations Oral herpes	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Pharyngitis	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	10.0% 1/10 • Number of events 1	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Pneumonia	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	9.1% 1/11 • Number of events 1	0.00% 0/10
Infections and infestations Rhinitis	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Sinusitis	5.7% 2/35 • Number of events 2	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	6.7% 1/15 • Number of events 1	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Staphylococcal impetigo	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	9.1% 1/11 • Number of events 1	0.00% 0/10
Infections and infestations Tonsillitis	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Tooth infection	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Upper respiratory tract infection	5.7% 2/35 • Number of events 2	10.0% 3/30 • Number of events 3	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Urethritis	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Infections and infestations Urinary tract infection	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	10.0% 2/20 • Number of events 2	0.00% 0/9	0.00% 0/11	0.00% 0/10
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	6.7% 1/15 • Number of events 1	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Injury, poisoning and procedural complications Contusion	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Injury, poisoning and procedural complications Foot fracture	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Injury, poisoning and procedural complications Rib fracture	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Injury, poisoning and procedural complications Thermal burn	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Injury, poisoning and procedural complications Traumatic ulcer	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Investigations Alanine aminotransferase increased	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	9.1% 1/11 • Number of events 1	0.00% 0/10
Investigations Blood pressure increased	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Investigations Hepatic enzyme increased	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Investigations Laboratory test abnormal	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Investigations Liver function test abnormal	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Investigations Lymph node palpable	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Investigations Weight decreased	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Metabolism and nutrition disorders Decreased appetite	2.9% 1/35 • Number of events 1	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	6.7% 1/15 • Number of events 1	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Metabolism and nutrition disorders Gout	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	9.1% 1/11 • Number of events 1	0.00% 0/10
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Metabolism and nutrition disorders Hypokalaemia	2.9% 1/35 • Number of events 1	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Metabolism and nutrition disorders Type 2 diabetes mellitus	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Bursitis	5.7% 2/35 • Number of events 3	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/35	6.7% 2/30 • Number of events 2	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/35	3.3% 1/30 • Number of events 1	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	11.4% 4/35 • Number of events 4	6.7% 2/30 • Number of events 2	22.9% 8/35 • Number of events 8	5.3% 1/19 • Number of events 1	0.00% 0/12	6.7% 1/15 • Number of events 1	18.2% 2/11 • Number of events 2	10.0% 1/10 • Number of events 1	5.0% 1/20 • Number of events 1	0.00% 0/9	9.1% 1/11 • Number of events 1	0.00% 0/10
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Tendonitis	2.9% 1/35 • Number of events 2	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	6.7% 1/15 • Number of events 1	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of adrenal gland	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal haemangioma	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Nervous system disorders Carpal tunnel syndrome	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	6.7% 1/15 • Number of events 1	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Nervous system disorders Depressed level of consciousness	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Nervous system disorders Dizziness	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Nervous system disorders Headache	2.9% 1/35 • Number of events 1	10.0% 3/30 • Number of events 3	5.7% 2/35 • Number of events 2	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Nervous system disorders Lumbar radiculopathy	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	6.7% 1/15 • Number of events 1	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Nervous system disorders Paraesthesia	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Nervous system disorders Syncope	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Psychiatric disorders Anxiety	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Psychiatric disorders Depression	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Psychiatric disorders Insomnia	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	9.1% 1/11 • Number of events 1	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Renal and urinary disorders Dysuria	2.9% 1/35 • Number of events 1	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Renal and urinary disorders Haematuria	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Renal and urinary disorders Renal colic	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Renal and urinary disorders Renal cyst	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Reproductive system and breast disorders Ovarian cyst	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Reproductive system and breast disorders Prostatitis	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Respiratory, thoracic and mediastinal disorders Cough	2.9% 1/35 • Number of events 1	0.00% 0/30	2.9% 1/35 • Number of events 2	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/35	0.00% 0/30	0.00% 0/35	5.3% 1/19 • Number of events 1	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Acne	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Alopecia	5.7% 2/35 • Number of events 3	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Dermatitis allergic	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Hyperhidrosis	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/35	3.3% 1/30 • Number of events 1	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Rash	0.00% 0/35	3.3% 1/30 • Number of events 1	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Rash maculo-papular	2.9% 1/35 • Number of events 1	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Rash papular	5.7% 2/35 • Number of events 2	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Skin ulcer	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Trichorrhexis	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Social circumstances Ex-tobacco user	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Surgical and medical procedures Bladder repair	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Surgical and medical procedures Hysterectomy	0.00% 0/35	0.00% 0/30	0.00% 0/35	0.00% 0/19	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Vascular disorders Aortic aneurysm	0.00% 0/35	3.3% 1/30 • Number of events 1	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Vascular disorders Hot flush	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Vascular disorders Hypertension	5.7% 2/35 • Number of events 2	3.3% 1/30 • Number of events 1	5.7% 2/35 • Number of events 2	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	5.0% 1/20 • Number of events 1	0.00% 0/9	0.00% 0/11	0.00% 0/10
Vascular disorders Hypotension	0.00% 0/35	0.00% 0/30	2.9% 1/35 • Number of events 1	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Vascular disorders Peripheral vascular disorder	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10
Vascular disorders Poor venous access	2.9% 1/35 • Number of events 1	0.00% 0/30	0.00% 0/35	0.00% 0/19	0.00% 0/12	0.00% 0/15	0.00% 0/11	0.00% 0/10	0.00% 0/20	0.00% 0/9	0.00% 0/11	0.00% 0/10

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