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A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01196091
Recruitment Status : Completed
First Posted : September 8, 2010
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Systemic Lupus Erythematosus
Connective Tissue Disease
Autoimmune Disease
Interventions Drug: LY2127399
Drug: Placebo every 2 weeks
Drug: Placebo every 4 weeks
Drug: Standard of Care
Enrollment 1164
Recruitment Details  
Pre-assignment Details Intent to Treat population (ITT) is all randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Period Title: Overall Study
Started 387 389 388
Received at Least 1 Dose of Study Drug 386 389 387
ITT-Received Drug and Excluded Sites 381 378 379
Follow-Up 103 105 128
Completed 299 291 284
Not Completed 88 98 104
Reason Not Completed
Adverse Event             22             27             26
Death             3             2             2
Entry Criteria Not Met             11             11             10
Lack of Efficacy             15             12             17
Lost to Follow-up             5             5             6
Parent/Caregiver Decision             0             0             1
Withdrawal by Subject             16             19             22
Physician Decision             3             3             4
Protocol Violation             1             3             3
Sponsor Decision             6             5             4
Excluded Site             5             11             8
Randomized, No Study Drug Received             1             0             1
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo Total
Hide Arm/Group Description LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose Total of all reporting groups
Overall Number of Baseline Participants 381 378 379 1138
Hide Baseline Analysis Population Description
Intent to Treat population (ITT) all randomized participants who received at least 1 dose of study drug: except those at Sites 301 and 383, which were excluded due to suspected good clinical practice (GCP) issues.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
39.8  (12.51) 40.2  (11.21) 39.1  (11.69) 39.7  (11.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
Female
354
  92.9%
352
  93.1%
360
  95.0%
1066
  93.7%
Male
27
   7.1%
26
   6.9%
19
   5.0%
72
   6.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
Hispanic or Latino
119
  31.2%
116
  30.7%
122
  32.2%
357
  31.4%
Not Hispanic or Latino
233
  61.2%
225
  59.5%
229
  60.4%
687
  60.4%
Unknown or Not Reported
29
   7.6%
37
   9.8%
28
   7.4%
94
   8.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
American Indian or Alaska Native
65
  17.1%
55
  14.6%
67
  17.7%
187
  16.4%
Asian
68
  17.8%
61
  16.1%
66
  17.4%
195
  17.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
Black or African American
40
  10.5%
41
  10.8%
39
  10.3%
120
  10.5%
White
204
  53.5%
218
  57.7%
205
  54.1%
627
  55.1%
More than one race
4
   1.0%
2
   0.5%
2
   0.5%
8
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
Colombia
16
   4.2%
10
   2.6%
18
   4.7%
44
   3.9%
Argentina
20
   5.2%
24
   6.3%
22
   5.8%
66
   5.8%
Puerto Rico
3
   0.8%
7
   1.9%
11
   2.9%
21
   1.8%
Singapore
0
   0.0%
2
   0.5%
0
   0.0%
2
   0.2%
United States
128
  33.6%
133
  35.2%
116
  30.6%
377
  33.1%
Philippines
26
   6.8%
14
   3.7%
22
   5.8%
62
   5.4%
Japan
15
   3.9%
15
   4.0%
15
   4.0%
45
   4.0%
Egypt
19
   5.0%
19
   5.0%
21
   5.5%
59
   5.2%
Ukraine
23
   6.0%
22
   5.8%
29
   7.7%
74
   6.5%
Thailand
14
   3.7%
9
   2.4%
11
   2.9%
34
   3.0%
Belarus
4
   1.0%
6
   1.6%
2
   0.5%
12
   1.1%
Canada
2
   0.5%
0
   0.0%
2
   0.5%
4
   0.4%
Austria
3
   0.8%
3
   0.8%
1
   0.3%
7
   0.6%
Macedonia
3
   0.8%
6
   1.6%
3
   0.8%
12
   1.1%
Poland
19
   5.0%
16
   4.2%
19
   5.0%
54
   4.7%
Guatemala
13
   3.4%
17
   4.5%
13
   3.4%
43
   3.8%
South Korea
11
   2.9%
18
   4.8%
14
   3.7%
43
   3.8%
Italy
1
   0.3%
7
   1.9%
2
   0.5%
10
   0.9%
Bulgaria
8
   2.1%
11
   2.9%
12
   3.2%
31
   2.7%
Chile
8
   2.1%
0
   0.0%
5
   1.3%
13
   1.1%
Peru
32
   8.4%
33
   8.7%
34
   9.0%
99
   8.7%
Germany
12
   3.1%
5
   1.3%
7
   1.8%
24
   2.1%
Croatia
1
   0.3%
1
   0.3%
0
   0.0%
2
   0.2%
Anti-dsDNA Antibody Level  
Mean (Standard Deviation)
Unit of measure:  International Units/Milliliter (IU/mL)
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
107.2  (113.50) 110.4  (111.58) 107.1  (112.40) 108.2  (112.41)
Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
10.2  (3.5) 10.4  (3.6) 10.7  (3.9) 10.4  (3.7)
[1]
Measure Description: Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score is a weighted, cumulative index of lupus disease activity. SELENA-SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
Physician's Global Assessment (PGA) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters (mm)
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
46.3  (15.7) 46.1  (16.2) 47.1  (16.10) 46.5  (16.0)
[1]
Measure Description: PGA is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 0 to 100-millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores range from 0, being worst possible to 100 being very active or best possible.
Time of Onset of Lupus  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
7.5  (7.4) 8.1  (7.9) 6.4  (6.8) 7.3  (7.4)
At Least One BILAG A or Two BILAG B Disease Activity Scores   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
Yes 360 340 347 1047
No 21 38 31 90
[1]
Measure Description:

The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.

The sum of participants in all Categories for the Measure does not equal the Overall Number of Baseline Participants in the Arm/Group because not all participants will have at least one BILAG A or Two BILAG B Disease Activity scores.

Lupus Quality of Life (lupus QOL) Domain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
Physical Health 59.2  (24.98) 59.1  (25.13) 56.9  (26.17) 58.4  (25.43)
Emotional Health 65.7  (25.19) 66.7  (23.99) 64.6  (26.22) 65.7  (25.14)
Body Image 61.1  (28.99) 63.2  (27.67) 61.9  (29.20) 62.1  (28.61)
Pain 56.1  (28.40) 56.9  (26.75) 53.6  (28.62) 55.5  (27.95)
Planning 61.2  (30.37) 62.1  (28.69) 59.0  (30.92) 60.8  (30.01)
Fatigue 56.0  (26.39) 54.4  (25.54) 53.4  (27.14) 54.6  (26.36)
Intimate Relationships 56.2  (33.92) 63.3  (31.53) 56.8  (34.21) 58.8  (33.36)
Burden to Others 52.8  (30.70) 51.9  (30.31) 49.3  (32.39) 51.3  (31.15)
[1]
Measure Description: The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.
Brief Fatigue Inventory (BFI) Score (Worst Level of Fatigue in the Last 24 Hours)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 381 participants 378 participants 379 participants 1138 participants
5.8  (2.57) 5.6  (2.81) 5.6  (2.81) 5.6  (2.73)
[1]
Measure Description: BFI is a participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine).
1.Primary Outcome
Title Percentage of Participants Achieving an SLE Responder Index Response at Week 52
Hide Description

Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.

SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.

Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population (ITT) all randomized participants who received at least 1 dose of study drug and evaluable SLE scores, excluding two sites' participants due to good clinical practice (GCP) issues.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Overall Number of Participants Analyzed 381 378 379
Measure Type: Number
Unit of Measure: percentage of participants
31.8 35.2 29.3
2.Secondary Outcome
Title Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
Hide Description A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit. Only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, a baseline use of prednisone or equivalent >7.5 mg/day, excluding two sites' participants due to good clinical practice (GCP) issues.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Overall Number of Participants Analyzed 197 200 196
Measure Type: Number
Unit of Measure: percentage of partipants
15.5 17.0 16.4
3.Secondary Outcome
Title Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level
Hide Description Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.
Time Frame Baseline, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues and a non-missing result at Week 52.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Overall Number of Participants Analyzed 381 378 377
Mean (Standard Deviation)
Unit of Measure: international units
107.2  (113.50) 110.4  (111.58) 107.1  (112.40)
4.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score
Hide Description SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
Time Frame Baseline, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Overall Number of Participants Analyzed 377 374 376
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.7  (4.35) -4.9  (4.32) -4.6  (4.54)
5.Secondary Outcome
Title Time to First Severe SLE Flare (SFI)
Hide Description

The SFI uses the SELENA-SLEDAI disease activity index score, disease activity scenarios, treatment changes, and PGA to define mild/moderate and severe flares. The index takes into account the absolute change in total scores, new or worsening symptoms, and increases in corticosteroid use or hospitalization due to the disease activity.

Time to first severe SLE flare (SFI) (in days) is calculated as: (Start date of first severe SLE flare (SFI) - Date of randomization + 1).

Time Frame Baseline through 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Time to first severe SLE flare data was not collected for analysis.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at first dose.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
Hide Description Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100 millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening is defined as increase of ≥0.3 points.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Overall Number of Participants Analyzed 381 378 379
Measure Type: Number
Unit of Measure: percentage of participants
64.3 61.4 58.0
7.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores
Hide Description A participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine).
Time Frame Baseline, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Overall Number of Participants Analyzed 362 363 361
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.9  (3.09) -0.9  (3.14) -0.6  (2.86)
8.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Hide Description The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.
Time Frame Baseline, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and a non-missing result.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Overall Number of Participants Analyzed 381 378 361
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Health Number Analyzed 121 participants 133 participants 111 participants
73.7  (26.05) 72.8  (24.53) 72.8  (23.70)
Emotional Health Number Analyzed 121 participants 133 participants 111 participants
75.2  (25.50) 72.4  (24.08) 73.1  (25.54)
Body Language Number Analyzed 117 participants 131 participants 108 participants
75.1  (26.21) 75.0  (24.82) 71.9  (28.90)
Pain Number Analyzed 121 participants 133 participants 111 participants
74.0  (27.42) 74.1  (24.94) 73.2  (27.30)
Planning Number Analyzed 121 participants 133 participants 111 participants
77.3  (26.53) 75.0  (29.07) 74.5  (28.93)
Fatigue Number Analyzed 121 participants 133 participants 111 participants
70.4  (25.51) 68.8  (26.34) 64.5  (24.94)
Intimate Relationships Number Analyzed 100 participants 124 participants 101 participants
77.4  (29.01) 68.8  (34.06) 68.7  (30.08)
Burden to Others Number Analyzed 121 participants 133 participants 111 participants
68.7  (30.43) 63.5  (30.34) 63.7  (30.21)
9.Secondary Outcome
Title Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares
Hide Description

The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.

Time to first BILAG A or two BILAG B flares (in days) is calculated as: (Start date of first BILAG A or two BILAG B flares - Date of randomization + 1). The two BILAG B flares must occur in different domains at the same visit.

Time Frame Baseline through 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Time first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares data was not collected for analysis.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in PGA
Hide Description Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores range from 0, being worst possible to 100 being very active or best possible.
Time Frame Baseline, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Overall Number of Participants Analyzed 375 374 375
Mean (Standard Deviation)
Unit of Measure: millimeters
-20.8  (21.97) -20.8  (22.33) -20.2  (22.42)
11.Secondary Outcome
Title Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks
Hide Description An increase in corticosteroids at a visit was defined as a change from baseline greater than 2.5 mg/day in dose or prednisone or equivalent using average daily dose of corticosteroids taken since the previous scheduled visit.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Overall Number of Participants Analyzed 381 378 379
Measure Type: Number
Unit of Measure: percentage of participants
6.7 9.1 8.8
12.Secondary Outcome
Title Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score
Hide Description Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score is a weighted, cumulative index of lupus disease activity. SELENA-SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
Time Frame Baseline, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Overall Number of Participants Analyzed 381 378 376
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.6  (4.19) -4.7  (4.11) -4.8  (4.47)
13.Secondary Outcome
Title Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks
Hide Description

Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score)

SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Patients who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.

Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
Overall Number of Participants Analyzed 381 378 379
Measure Type: Number
Unit of Measure: percentage of participants
Responder 31.8 35.2 29.6
Non-Responder 68.2 64.8 70.4
14.Secondary Outcome
Title Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline
Hide Description

The BILAG2004 index is a validated global disease activity index designed on the basis of the physician's ITT, focusing on changes in disease manifestations (new, improved, worsening, etc) occurring in the last 4 weeks compared with the previous 4 weeks.

The instrument assesses 97 clinical signs, symptoms, and laboratory parameters across 9 organ system domains: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, opthalmic, renal and hematology.

Time Frame Baseline through 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo
Hide Arm/Group Description:
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
Overall Number of Participants Analyzed 381 378 379
Measure Type: Count of Participants
Unit of Measure: Participants
247 234 219
Time Frame [Not Specified]
Adverse Event Reporting Description All participants who received at least 1 dose of study drug.
 
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo LY2127399 Every 2 Weeks, Follow Up LY2127399 Every 4 Wks, Follow Up Placebo, Follow Up
Hide Arm/Group Description LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.

Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose 24-48 weeks post last dose 24-48 weeks post last dose 24-48 weeks post last dose
All-Cause Mortality
LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo LY2127399 Every 2 Weeks, Follow Up LY2127399 Every 4 Wks, Follow Up Placebo, Follow Up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo LY2127399 Every 2 Weeks, Follow Up LY2127399 Every 4 Wks, Follow Up Placebo, Follow Up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/386 (10.88%)      56/389 (14.40%)      50/387 (12.92%)      14/103 (13.59%)      16/105 (15.24%)      23/128 (17.97%)    
Blood and lymphatic system disorders             
Antiphospholipid syndrome  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Autoimmune haemolytic anaemia  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Febrile neutropenia  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Haemorrhagic anaemia  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Histiocytosis haematophagic  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Leukopenia  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Neutropenia  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Thrombocytopenia  1  0/386 (0.00%)  0 2/389 (0.51%)  3 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Thrombocytosis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Cardiac disorders             
Acute myocardial infarction  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Atrioventricular block complete  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Cardiac arrest  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Cardiac failure  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Cardiac failure congestive  1  2/386 (0.52%)  2 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Coronary artery disease  1  0/386 (0.00%)  0 0/389 (0.00%)  0 2/387 (0.52%)  2 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Lupus endocarditis  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Mitral valve prolapse  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Myocarditis  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  2 0/105 (0.00%)  0 0/128 (0.00%)  0
Pericarditis  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Supraventricular tachycardia  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Ventricular fibrillation  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Congenital, familial and genetic disorders             
Sickle cell anaemia with crisis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastrointestinal disorders             
Abdominal hernia  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Constipation  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Enterocolitis  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastric ulcer  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastritis  1  2/386 (0.52%)  2 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastritis atrophic  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastrointestinal haemorrhage  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastrointestinal inflammation  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastrooesophageal reflux disease  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Obstruction gastric  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pancreatitis  1  1/386 (0.26%)  1 1/389 (0.26%)  1 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pancreatitis acute  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Rectal ulcer  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Varices oesophageal  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Vasculitis gastrointestinal  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Vomiting  1  1/386 (0.26%)  1 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
General disorders             
Death  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Generalised oedema  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Non-cardiac chest pain  1  0/386 (0.00%)  0 0/389 (0.00%)  0 2/387 (0.52%)  2 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Pyrexia  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Hepatobiliary disorders             
Cholecystitis acute  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Cholelithiasis  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Hepatic steatosis  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Immune system disorders             
Type III immune complex mediated reaction  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Infections and infestations             
Abscess limb  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Appendicitis  1  2/386 (0.52%)  2 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Arthritis bacterial  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 1/105 (0.95%)  1 0/128 (0.00%)  0
Bronchitis  1  0/386 (0.00%)  0 1/389 (0.26%)  1 2/387 (0.52%)  2 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Cellulitis  1  1/386 (0.26%)  1 2/389 (0.51%)  2 1/387 (0.26%)  2 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Device related infection  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Disseminated tuberculosis  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Diverticulitis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastroenteritis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastroenteritis norovirus  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Gastroenteritis viral  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Haematoma infection  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Herpes zoster  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Infected skin ulcer  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Klebsiella bacteraemia  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Lung infection  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Mycobacterial infection  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Oral candidiasis  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Osteomyelitis  1  1/386 (0.26%)  1 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Pancreas infection  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Parotitis  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pharyngotonsillitis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pneumonia  1  5/386 (1.30%)  5 8/389 (2.06%)  9 4/387 (1.03%)  4 0/103 (0.00%)  0 2/105 (1.90%)  2 1/128 (0.78%)  1
Pneumonia viral  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Post procedural infection  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pyelonephritis  1  1/386 (0.26%)  1 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pyelonephritis acute  1  1/386 (0.26%)  1 1/389 (0.26%)  1 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Respiratory tract infection  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Salpingo-oophoritis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Sepsis  1  1/386 (0.26%)  2 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Sinusitis  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Sinusitis bacterial  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Staphylococcal bacteraemia  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Staphylococcal infection  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Staphylococcal skin infection  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Superinfection bacterial  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Tracheobronchitis  1  2/386 (0.52%)  2 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Upper respiratory tract infection  1  3/386 (0.78%)  3 1/389 (0.26%)  1 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Urinary tract infection  1  7/386 (1.81%)  7 2/389 (0.51%)  2 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Viral infection  1  1/386 (0.26%)  1 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Injury, poisoning and procedural complications             
Compression fracture  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Fall  1  0/386 (0.00%)  0 3/389 (0.77%)  3 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Foot fracture  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Humerus fracture  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Incisional hernia  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Medication error  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Overdose  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Radius fracture  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Spinal fracture  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Tendon rupture  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Thoracic vertebral fracture  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Toxicity to various agents  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Wrist fracture  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Investigations             
Haemoglobin decreased  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Weight increased  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Metabolism and nutrition disorders             
Diabetes mellitus inadequate control  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Fluid overload  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Hyponatraemia  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Arthritis  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Cervical spinal stenosis  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Intervertebral disc degeneration  1  0/386 (0.00%)  0 2/389 (0.51%)  2 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Intervertebral disc protrusion  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Musculoskeletal chest pain  1  0/386 (0.00%)  0 2/389 (0.51%)  2 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Osteoarthritis  1  1/386 (0.26%)  1 1/389 (0.26%)  1 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Osteonecrosis  1  0/386 (0.00%)  0 1/389 (0.26%)  1 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Pain in extremity  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Polyarthritis  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
SLE arthritis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Systemic lupus erythematosus  1  2/386 (0.52%)  2 4/389 (1.03%)  4 5/387 (1.29%)  5 4/103 (3.88%)  4 1/105 (0.95%)  1 2/128 (1.56%)  3
Tendon disorder  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Breast cancer  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Brenner tumour  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Haemangioma  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Intestinal adenocarcinoma  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Uterine leiomyoma  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Nervous system disorders             
Central nervous system inflammation  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Cerebral venous thrombosis  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Cerebrovascular accident  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 1/103 (0.97%)  1 1/105 (0.95%)  1 0/128 (0.00%)  0
Convulsion  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Headache  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Ischaemic stroke  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Migraine  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Neuropsychiatric lupus  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 1/105 (0.95%)  1 0/128 (0.00%)  0
Radiculopathy  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Syncope  1  1/386 (0.26%)  1 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Vasculitis cerebral  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Vertebrobasilar insufficiency  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pregnancy, puerperium and perinatal conditions             
Abortion spontaneous  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Pre-eclampsia  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Psychiatric disorders             
Affect lability  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Affective disorder  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Anxiety  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Depression  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Generalised anxiety disorder  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Major depression  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Mental disorder due to a general medical condition  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Psychotic disorder  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Suicidal ideation  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Suicide attempt  1  0/386 (0.00%)  0 1/389 (0.26%)  1 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Renal and urinary disorders             
Calculus ureteric  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Glomerulonephritis proliferative  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Lupus cystitis  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Lupus nephritis  1  2/386 (0.52%)  2 1/389 (0.26%)  1 4/387 (1.03%)  4 3/103 (2.91%)  3 0/105 (0.00%)  0 7/128 (5.47%)  7
Mesangioproliferative glomerulonephritis  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Nephrolithiasis  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Nephrotic syndrome  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Renal failure  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Renal failure acute  1  0/386 (0.00%)  0 1/389 (0.26%)  1 1/387 (0.26%)  1 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Renal failure chronic  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Reproductive system and breast disorders             
Adenomyosis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Ovarian cyst  1  1/386 (0.26%)  1 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 1/105 (0.95%)  1 0/128 (0.00%)  0
Ovarian cyst ruptured  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pelvic pain  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Asthma  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Atelectasis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Chronic obstructive pulmonary disease  1  1/386 (0.26%)  1 1/389 (0.26%)  1 2/387 (0.52%)  2 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pleural effusion  1  1/386 (0.26%)  2 1/389 (0.26%)  1 2/387 (0.52%)  2 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Pleuritic pain  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Pneumonitis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Pulmonary embolism  1  1/386 (0.26%)  1 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Respiratory failure  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Skin and subcutaneous tissue disorders             
Cutaneous lupus erythematosus  1  1/386 (0.26%)  1 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Erythema multiforme  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Hypersensitivity vasculitis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Systemic lupus erythematosus rash  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 1/103 (0.97%)  1 0/105 (0.00%)  0 0/128 (0.00%)  0
Surgical and medical procedures             
Female sterilisation  1  0/386 (0.00%)  0 0/389 (0.00%)  0 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Vascular disorders             
Deep vein thrombosis  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Femoral artery occlusion  1  0/386 (0.00%)  0 1/389 (0.26%)  1 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Haematoma  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Hypertension  1  2/386 (0.52%)  2 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Thrombosis  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 0/105 (0.00%)  0 1/128 (0.78%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
LY2127399 Every 2 Weeks LY2127399 Every 4 Wks Placebo LY2127399 Every 2 Weeks, Follow Up LY2127399 Every 4 Wks, Follow Up Placebo, Follow Up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   250/386 (64.77%)      243/389 (62.47%)      246/387 (63.57%)      13/103 (12.62%)      11/105 (10.48%)      13/128 (10.16%)    
Eye disorders             
Dry eye  1  8/386 (2.07%)  8 3/389 (0.77%)  3 1/387 (0.26%)  1 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastrointestinal disorders             
Abdominal pain  1  8/386 (2.07%)  8 12/389 (3.08%)  14 12/387 (3.10%)  12 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Abdominal pain upper  1  10/386 (2.59%)  11 11/389 (2.83%)  12 11/387 (2.84%)  11 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Constipation  1  11/386 (2.85%)  11 7/389 (1.80%)  7 11/387 (2.84%)  11 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Diarrhoea  1  22/386 (5.70%)  26 29/389 (7.46%)  33 23/387 (5.94%)  30 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Dyspepsia  1  8/386 (2.07%)  9 8/389 (2.06%)  8 10/387 (2.58%)  17 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastritis  1  12/386 (3.11%)  13 6/389 (1.54%)  6 7/387 (1.81%)  7 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastrooesophageal reflux disease  1  11/386 (2.85%)  11 7/389 (1.80%)  7 7/387 (1.81%)  9 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Nausea  1  17/386 (4.40%)  19 31/389 (7.97%)  42 21/387 (5.43%)  24 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Vomiting  1  16/386 (4.15%)  19 14/389 (3.60%)  17 11/387 (2.84%)  12 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
General disorders             
Fatigue  1  10/386 (2.59%)  12 15/389 (3.86%)  16 10/387 (2.58%)  11 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Injection site reaction  1  11/386 (2.85%)  17 7/389 (1.80%)  10 6/387 (1.55%)  8 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Oedema peripheral  1  11/386 (2.85%)  11 8/389 (2.06%)  9 10/387 (2.58%)  11 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pyrexia  1  8/386 (2.07%)  9 10/389 (2.57%)  14 8/387 (2.07%)  16 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Infections and infestations             
Bronchitis  1  15/386 (3.89%)  18 19/389 (4.88%)  19 17/387 (4.39%)  19 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Conjunctivitis  1  9/386 (2.33%)  11 8/389 (2.06%)  10 6/387 (1.55%)  6 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Cystitis  1  4/386 (1.04%)  5 8/389 (2.06%)  8 9/387 (2.33%)  10 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Gastroenteritis  1  10/386 (2.59%)  11 9/389 (2.31%)  10 11/387 (2.84%)  12 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Herpes zoster  1  13/386 (3.37%)  13 4/389 (1.03%)  5 9/387 (2.33%)  9 1/103 (0.97%)  1 2/105 (1.90%)  2 3/128 (2.34%)  3
Influenza  1  9/386 (2.33%)  10 5/389 (1.29%)  5 6/387 (1.55%)  6 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Nasopharyngitis  1  29/386 (7.51%)  46 33/389 (8.48%)  35 37/387 (9.56%)  48 3/103 (2.91%)  3 0/105 (0.00%)  0 1/128 (0.78%)  1
Oral candidiasis  1  6/386 (1.55%)  7 3/389 (0.77%)  3 8/387 (2.07%)  9 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pharyngitis  1  13/386 (3.37%)  17 18/389 (4.63%)  19 14/387 (3.62%)  18 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Sinusitis  1  16/386 (4.15%)  22 15/389 (3.86%)  16 11/387 (2.84%)  11 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Upper respiratory tract infection  1  55/386 (14.25%)  86 41/389 (10.54%)  55 51/387 (13.18%)  72 3/103 (2.91%)  3 3/105 (2.86%)  3 4/128 (3.13%)  4
Urinary tract infection  1  68/386 (17.62%)  100 52/389 (13.37%)  76 51/387 (13.18%)  77 6/103 (5.83%)  6 2/105 (1.90%)  2 4/128 (3.13%)  4
Vulvovaginal mycotic infection  1  7/386 (1.81%)  7 9/389 (2.31%)  12 8/387 (2.07%)  11 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Metabolism and nutrition disorders             
Hypertriglyceridaemia  1  8/386 (2.07%)  9 4/389 (1.03%)  5 2/387 (0.52%)  2 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Hypokalaemia  1  9/386 (2.33%)  11 1/389 (0.26%)  1 3/387 (0.78%)  4 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  14/386 (3.63%)  15 15/389 (3.86%)  17 11/387 (2.84%)  14 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Back pain  1  15/386 (3.89%)  15 28/389 (7.20%)  30 19/387 (4.91%)  24 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Muscle spasms  1  4/386 (1.04%)  5 8/389 (2.06%)  8 7/387 (1.81%)  7 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Musculoskeletal chest pain  1  2/386 (0.52%)  2 8/389 (2.06%)  8 8/387 (2.07%)  8 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Musculoskeletal pain  1  1/386 (0.26%)  1 6/389 (1.54%)  6 10/387 (2.58%)  12 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Myalgia  1  9/386 (2.33%)  11 6/389 (1.54%)  6 9/387 (2.33%)  9 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Pain in extremity  1  7/386 (1.81%)  8 5/389 (1.29%)  7 8/387 (2.07%)  9 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Nervous system disorders             
Dizziness  1  6/386 (1.55%)  6 19/389 (4.88%)  31 15/387 (3.88%)  15 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Headache  1  34/386 (8.81%)  48 35/389 (9.00%)  56 45/387 (11.63%)  54 0/103 (0.00%)  0 3/105 (2.86%)  3 0/128 (0.00%)  0
Pregnancy, puerperium and perinatal conditions             
Pregnancy  1  0/386 (0.00%)  0 0/389 (0.00%)  0 0/387 (0.00%)  0 0/103 (0.00%)  0 2/105 (1.90%)  2 1/128 (0.78%)  1
Psychiatric disorders             
Anxiety  1  6/386 (1.55%)  7 8/389 (2.06%)  8 6/387 (1.55%)  7 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Depression  1  7/386 (1.81%)  7 12/389 (3.08%)  13 12/387 (3.10%)  12 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Insomnia  1  22/386 (5.70%)  22 17/389 (4.37%)  17 16/387 (4.13%)  17 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  10/386 (2.59%)  11 12/389 (3.08%)  13 18/387 (4.65%)  18 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Skin and subcutaneous tissue disorders             
Rash  1  5/386 (1.30%)  5 6/389 (1.54%)  6 10/387 (2.58%)  11 0/103 (0.00%)  0 0/105 (0.00%)  0 0/128 (0.00%)  0
Vascular disorders             
Hypertension  1  14/386 (3.63%)  14 13/389 (3.34%)  13 20/387 (5.17%)  21 4/103 (3.88%)  4 0/105 (0.00%)  0 0/128 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Due to product program termination, not all analyses were completed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01196091     History of Changes
Other Study ID Numbers: 13656
H9B-MC -BCDS ( Other Identifier: Eli Lilly and Company )
First Submitted: September 3, 2010
First Posted: September 8, 2010
Results First Submitted: March 24, 2018
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018