Illuminate-X: On Open-Label Study in Participants With Systemic Lupus Erythematosus
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT01488708
Collaborator
(none)
1,518
1
2
45
33.8
Study Details
Study Description
Brief Summary
The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399 in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1518 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)
Study Start Date
:
Jan 1, 2012
Actual Primary Completion Date
:
Oct 1, 2015
Actual Study Completion Date
:
Oct 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY 2127399 Q2W If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. |
Drug: LY2127399
120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.
Drug: Placebo
Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.
|
| Experimental: LY2127399 Q4W If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. |
Drug: LY2127399
120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.
Drug: Placebo
Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Adverse Events (AEs) [Baseline through 4 years]
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Secondary Outcome Measures
- Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response [Week 48]
- Proportion of Participants With a Reduction in Steroid Dose [Baseline through 4 years]
- Change in SLE Disease Activity Index [Baseline, 4 years]
- Occurrence of New Severe SLE Flares [Baseline through 4 years]
- Proportion of Participants With Improvement in Lupus Quality of Life [4 years]
- Change in Anti-double-stranded Deoxyribonucleic Acid Level [Baseline, 4 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have completed 52 weeks of treatment in core studies (NCT01196091) (NCT01205438)
-
Given written informed consent
-
Test negative for pregnancy at the time of enrollment
-
Agree to use a reliable method of birth control
Exclusion Criteria:
-
Unwilling to comply with study procedures
-
Any condition that renders the participants unable to understand the nature and scope and possible consequences of the study
-
Any condition that in the opinion of the investigator poses an unacceptable risk to the participants if study drug would be administered
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician | Irving | Texas | United States | 75061 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY(1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT-5 hours, EST, Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01488708
Other Study ID Numbers:
- 13811
- H9B-MC-BCDX
First Posted:
Dec 8, 2011
Last Update Posted:
May 17, 2018
Last Verified:
May 1, 2018
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | LY 2127399 Q2W | LY2127399 Q4W |
|---|---|---|
| Arm/Group Description | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| Period Title: Overall Study | ||
| STARTED | 940 | 578 |
| Received at Least 1 Dose of Study Drug | 937 | 578 |
| Participated in Follow Up | 810 | 526 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 940 | 578 |
Baseline Characteristics
| Arm/Group Title | LY 2127399 Q2W | LY2127399 Q4W | Total |
|---|---|---|---|
| Arm/Group Description | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | Total of all reporting groups |
| Overall Participants | 940 | 578 | 1518 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
43.6
(12.12)
|
40.4
(11.35)
|
42.4
(11.93)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
880
93.6%
|
527
91.2%
|
1407
92.7%
|
| Male |
60
6.4%
|
51
8.8%
|
111
7.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
265
28.2%
|
189
32.7%
|
454
29.9%
|
| Not Hispanic or Latino |
612
65.1%
|
314
54.3%
|
926
61%
|
| Unknown or Not Reported |
63
6.7%
|
75
13%
|
138
9.1%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
104
11.1%
|
94
16.3%
|
198
13%
|
| Asian |
113
12%
|
96
16.6%
|
209
13.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
0.2%
|
1
0.1%
|
| Black or African American |
130
13.8%
|
33
5.7%
|
163
10.7%
|
| White |
579
61.6%
|
337
58.3%
|
916
60.3%
|
| More than one race |
14
1.5%
|
17
2.9%
|
31
2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
449
47.8%
|
83
14.4%
|
532
35%
|
| Puerto Rico |
14
1.5%
|
1
0.2%
|
15
1%
|
| Canada |
3
0.3%
|
3
0.5%
|
6
0.4%
|
| Peru |
31
3.3%
|
38
6.6%
|
69
4.5%
|
| Brazil |
18
1.9%
|
36
6.2%
|
54
3.6%
|
| Mexico |
23
2.4%
|
28
4.8%
|
51
3.4%
|
| Ecuador |
21
2.2%
|
20
3.5%
|
41
2.7%
|
| Argentina |
16
1.7%
|
23
4%
|
39
2.6%
|
| Colombia |
18
1.9%
|
12
2.1%
|
30
2%
|
| Guatemala |
14
1.5%
|
16
2.8%
|
30
2%
|
| Chile |
7
0.7%
|
3
0.5%
|
10
0.7%
|
| Philippines |
33
3.5%
|
26
4.5%
|
59
3.9%
|
| Taiwan |
22
2.3%
|
20
3.5%
|
42
2.8%
|
| Japan |
17
1.8%
|
19
3.3%
|
36
2.4%
|
| South Korea |
15
1.6%
|
14
2.4%
|
29
1.9%
|
| Thailand |
14
1.5%
|
10
1.7%
|
24
1.6%
|
| Australia |
6
0.6%
|
3
0.5%
|
9
0.6%
|
| New Zealand |
2
0.2%
|
3
0.5%
|
5
0.3%
|
| Malaysia |
2
0.2%
|
0
0%
|
2
0.1%
|
| Singapore |
0
0%
|
1
0.2%
|
1
0.1%
|
| Serbia |
27
2.9%
|
36
6.2%
|
63
4.2%
|
| Hungary |
21
2.2%
|
23
4%
|
44
2.9%
|
| Poland |
22
2.3%
|
19
3.3%
|
41
2.7%
|
| Russia |
17
1.8%
|
21
3.6%
|
38
2.5%
|
| Ukraine |
14
1.5%
|
17
2.9%
|
31
2%
|
| Romania |
13
1.4%
|
10
1.7%
|
23
1.5%
|
| Spain |
10
1.1%
|
12
2.1%
|
22
1.4%
|
| Germany |
11
1.2%
|
4
0.7%
|
15
1%
|
| Belarus |
4
0.4%
|
7
1.2%
|
11
0.7%
|
| Bulgaria |
7
0.7%
|
4
0.7%
|
11
0.7%
|
| Latvia |
5
0.5%
|
4
0.7%
|
9
0.6%
|
| Macedonia |
5
0.5%
|
3
0.5%
|
8
0.5%
|
| Austria |
1
0.1%
|
3
0.5%
|
4
0.3%
|
| Italy |
1
0.1%
|
2
0.3%
|
3
0.2%
|
| Croatia |
1
0.1%
|
1
0.2%
|
2
0.1%
|
| France |
1
0.1%
|
1
0.2%
|
2
0.1%
|
| Tunisia |
21
2.2%
|
19
3.3%
|
40
2.6%
|
| South Africa |
13
1.4%
|
18
3.1%
|
31
2%
|
| Israel |
13
1.4%
|
9
1.6%
|
22
1.4%
|
| Egypt |
5
0.5%
|
4
0.7%
|
9
0.6%
|
| United Kingdom |
3
0.3%
|
2
0.3%
|
5
0.3%
|
| Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
5.4
(3.81)
|
4.9
(3.74)
|
5.2
(3.79)
|
| Anti-dsDNA Antibody Level (IU) (International Unit/Milliliter (IU/mL)) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [International Unit/Milliliter (IU/mL)] |
82.9
(102.03)
|
92.3
(102.35)
|
86.4
(102.23)
|
Outcome Measures
| Title | Percentage of Participants With Adverse Events (AEs) |
|---|---|
| Description | A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. |
| Time Frame | Baseline through 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study drug. |
| Arm/Group Title | LY 2127399 Q2W | LY2127399 Q4W |
|---|---|---|
| Arm/Group Description | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| Measure Participants | 937 | 578 |
| Number [percentage of participants] |
73.3
7.8%
|
65.6
11.3%
|
| Title | Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response |
|---|---|
| Description | |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participants analyzed. Data was not collected for analysis. |
| Arm/Group Title | LY 2127399 Q2W | LY2127399 Q4W |
|---|---|---|
| Arm/Group Description | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| Measure Participants | 0 | 0 |
| Title | Proportion of Participants With a Reduction in Steroid Dose |
|---|---|
| Description | |
| Time Frame | Baseline through 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participants analyzed. Data was not collected for analysis. |
| Arm/Group Title | LY 2127399 Q2W | LY2127399 Q4W |
|---|---|---|
| Arm/Group Description | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| Measure Participants | 0 | 0 |
| Title | Change in SLE Disease Activity Index |
|---|---|
| Description | |
| Time Frame | Baseline, 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participants analyzed. Data was not collected for analysis. |
| Arm/Group Title | LY 2127399 Q2W | LY2127399 Q4W |
|---|---|---|
| Arm/Group Description | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| Measure Participants | 0 | 0 |
| Title | Occurrence of New Severe SLE Flares |
|---|---|
| Description | |
| Time Frame | Baseline through 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participants analyzed. Data was not collected for analysis. |
| Arm/Group Title | LY 2127399 Q2W | LY2127399 Q4W |
|---|---|---|
| Arm/Group Description | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| Measure Participants | 0 | 0 |
| Title | Proportion of Participants With Improvement in Lupus Quality of Life |
|---|---|
| Description | |
| Time Frame | 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participants analyzed. Data was not collected for analysis. |
| Arm/Group Title | LY 2127399 Q2W | LY2127399 Q4W |
|---|---|---|
| Arm/Group Description | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| Measure Participants | 0 | 0 |
| Title | Change in Anti-double-stranded Deoxyribonucleic Acid Level |
|---|---|
| Description | |
| Time Frame | Baseline, 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participants analyzed. Data was not collected for analysis. |
| Arm/Group Title | LY 2127399 Q2W | LY2127399 Q4W |
|---|---|---|
| Arm/Group Description | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All randomized participants who received at least 1 dose of study drug. | |||||||
| Arm/Group Title | LY 2127399 Q2W Treatment | LY2127399 Q4W Treatment | LY 2127399 Q2W Follow Up | LY2127399 Q4W Follow Up | ||||
| Arm/Group Description | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. Follow up. | If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. Follow up. | ||||
All Cause Mortality |
||||||||
| LY 2127399 Q2W Treatment | LY2127399 Q4W Treatment | LY 2127399 Q2W Follow Up | LY2127399 Q4W Follow Up | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| LY 2127399 Q2W Treatment | LY2127399 Q4W Treatment | LY 2127399 Q2W Follow Up | LY2127399 Q4W Follow Up | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 129/937 (13.8%) | 64/578 (11.1%) | 57/810 (7%) | 51/526 (9.7%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Anaemia macrocytic | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Autoimmune haemolytic anaemia | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Febrile neutropenia | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Haemolytic anaemia | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Haemolytic uraemic syndrome | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Haemorrhagic anaemia | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Histiocytosis haematophagic | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Iron deficiency anaemia | 3/937 (0.3%) | 3 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Leukopenia | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Lymphopenia | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Microcytic anaemia | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Neutropenia | 1/937 (0.1%) | 1 | 2/578 (0.3%) | 2 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Thrombocytopenia | 1/937 (0.1%) | 1 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Thrombotic thrombocytopenic purpura | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Cardiac disorders | ||||||||
| Acute myocardial infarction | 3/937 (0.3%) | 3 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Angina pectoris | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Atrioventricular block | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Atrioventricular block complete | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Atrioventricular block second degree | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Bundle branch block bilateral | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Cardiac arrest | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Cardiac failure congestive | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Cardio-respiratory arrest | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Coronary artery disease | 2/937 (0.2%) | 2 | 1/578 (0.2%) | 1 | 1/810 (0.1%) | 1 | 1/526 (0.2%) | 1 |
| Myocardial fibrosis | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Myocardial infarction | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pericardial effusion | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pericarditis | 1/937 (0.1%) | 1 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Right ventricular failure | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Tachycardia | 0/937 (0%) | 0 | 2/578 (0.3%) | 2 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Tricuspid valve disease | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||
| Vertigo | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Endocrine disorders | ||||||||
| Adrenal insufficiency | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Adrenocortical insufficiency acute | 1/937 (0.1%) | 3 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Mineralocorticoid deficiency | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Eye disorders | ||||||||
| Amaurosis fugax | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Cataract | 0/937 (0%) | 0 | 1/578 (0.2%) | 2 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Diplopia | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Eyelid ptosis | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 4/937 (0.4%) | 4 | 2/578 (0.3%) | 2 | 1/810 (0.1%) | 1 | 1/526 (0.2%) | 1 |
| Colitis | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Colitis ulcerative | 1/937 (0.1%) | 1 | 1/578 (0.2%) | 1 | 2/810 (0.2%) | 2 | 0/526 (0%) | 0 |
| Constipation | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Gastric ulcer perforation | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Gastritis | 3/937 (0.3%) | 3 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Gastritis erosive | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Gastrointestinal haemorrhage | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Gastrooesophageal reflux disease | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Haemorrhoidal haemorrhage | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Hiatus hernia | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Intestinal ischaemia | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Intestinal perforation | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Large intestine polyp | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Oesophagitis | 1/937 (0.1%) | 1 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pancreatitis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pancreatitis acute | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Rectal haemorrhage | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Retroperitoneal haemorrhage | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Small intestinal obstruction | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| General disorders | ||||||||
| Death | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Device dislocation | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Implant site erosion | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Medical device complication | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Non-cardiac chest pain | 1/937 (0.1%) | 1 | 1/578 (0.2%) | 1 | 3/810 (0.4%) | 3 | 0/526 (0%) | 0 |
| Pelvic mass | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pyrexia | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 2/810 (0.2%) | 3 | 0/526 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Cholecystitis | 3/937 (0.3%) | 3 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Cholecystitis acute | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Cholecystitis chronic | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Cholelithiasis | 1/937 (0.1%) | 1 | 1/578 (0.2%) | 1 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Drug-induced liver injury | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 1/526 (0.2%) | 1 |
| Hepatic function abnormal | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Liver disorder | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Nodular regenerative hyperplasia | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Immune system disorders | ||||||||
| Drug hypersensitivity | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Infections and infestations | ||||||||
| Abdominal abscess | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Abscess | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Amoebiasis | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Appendicitis | 2/937 (0.2%) | 2 | 2/578 (0.3%) | 2 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Arthritis bacterial | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Bacteraemia | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Blastocystis infection | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Brain abscess | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Bronchitis | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Bronchitis bacterial | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Cellulitis | 3/937 (0.3%) | 3 | 1/578 (0.2%) | 1 | 3/810 (0.4%) | 3 | 1/526 (0.2%) | 1 |
| Cervicitis | 0/877 (0%) | 0 | 1/527 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Cytomegalovirus infection | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Diverticulitis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 1/526 (0.2%) | 1 |
| Enterocolitis bacterial | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Escherichia urinary tract infection | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Gastroenteritis | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Groin abscess | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Herpes zoster | 1/937 (0.1%) | 1 | 1/578 (0.2%) | 1 | 1/810 (0.1%) | 1 | 2/526 (0.4%) | 2 |
| Herpes zoster disseminated | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Infectious colitis | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Influenza | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Kidney infection | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Lobar pneumonia | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 1/526 (0.2%) | 1 |
| Localised infection | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Meningitis | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Meningitis cryptococcal | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Meningitis viral | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Oesophageal candidiasis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Ophthalmic herpes zoster | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Oral fungal infection | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Peritonitis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Peritonsillar abscess | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pharyngotonsillitis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pneumococcal sepsis | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Pneumonia | 11/937 (1.2%) | 12 | 1/578 (0.2%) | 1 | 1/810 (0.1%) | 1 | 1/526 (0.2%) | 1 |
| Pneumonia bacterial | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Post procedural infection | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Pulmonary tuberculosis | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 1/810 (0.1%) | 1 | 1/526 (0.2%) | 1 |
| Pyelonephritis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pyonephrosis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Respiratory tract infection | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Sepsis | 3/937 (0.3%) | 3 | 1/578 (0.2%) | 1 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Sepsis syndrome | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Septic shock | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Sinusitis | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Staphylococcal sepsis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Staphylococcal skin infection | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Subcutaneous abscess | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Tooth abscess | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Upper respiratory tract infection | 3/937 (0.3%) | 3 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Urinary tract infection | 3/937 (0.3%) | 3 | 3/578 (0.5%) | 3 | 2/810 (0.2%) | 2 | 3/526 (0.6%) | 3 |
| Varicella | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Viral infection | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 1/526 (0.2%) | 1 |
| Vulval cellulitis | 1/877 (0.1%) | 1 | 0/527 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Ankle fracture | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Bone fissure | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Bronchial injury | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Concussion | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Contusion | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Fall | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Femoral neck fracture | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Femur fracture | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Fibula fracture | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Gun shot wound | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Head injury | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Joint injury | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Ligament rupture | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Ligament sprain | 1/937 (0.1%) | 3 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Muscle strain | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Overdose | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Procedural intestinal perforation | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Respiratory fume inhalation disorder | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Road traffic accident | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Spinal compression fracture | 3/937 (0.3%) | 3 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Subdural haematoma | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Vascular pseudoaneurysm | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Investigations | ||||||||
| Electrocardiogram QRS complex shortened | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Lipase increased | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Cholesterosis | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Dehydration | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Diabetes mellitus | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Diabetes mellitus inadequate control | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Hyperglycaemia | 1/937 (0.1%) | 2 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Hypoglycaemia | 0/937 (0%) | 0 | 2/578 (0.3%) | 2 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Ketosis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Metabolic acidosis | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthritis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Back pain | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Bursitis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Chondrocalcinosis pyrophosphate | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Costochondritis | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Intervertebral disc protrusion | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Lumbar spinal stenosis | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Muscle haemorrhage | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Muscular weakness | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Musculoskeletal chest pain | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Musculoskeletal pain | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Osteoarthritis | 2/937 (0.2%) | 2 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Osteonecrosis | 8/937 (0.9%) | 9 | 2/578 (0.3%) | 2 | 2/810 (0.2%) | 2 | 0/526 (0%) | 0 |
| Pain in extremity | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| SLE arthritis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Spinal osteoarthritis | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Systemic lupus erythematosus | 4/937 (0.4%) | 4 | 3/578 (0.5%) | 4 | 1/810 (0.1%) | 1 | 5/526 (1%) | 5 |
| Tendon disorder | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Basal cell carcinoma | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Benign breast neoplasm | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Benign vaginal neoplasm | 1/877 (0.1%) | 1 | 0/527 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Breast cancer | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Brenner tumour | 1/877 (0.1%) | 1 | 0/527 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Haemangioma | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Neuroendocrine tumour | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Prostate cancer | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/50 (0%) | 0 | 1/44 (2.3%) | 1 |
| Squamous cell carcinoma of skin | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Squamous cell carcinoma of the cervix | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/760 (0%) | 0 | 1/482 (0.2%) | 1 |
| Uterine cancer | 1/877 (0.1%) | 1 | 0/527 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Uterine leiomyoma | 1/877 (0.1%) | 1 | 0/527 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Nervous system disorders | ||||||||
| Autonomic nervous system imbalance | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Carotid artery dissection | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Cerebrovascular disorder | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Epilepsy | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Headache | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Hemiparesis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| IIIrd nerve disorder | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Migraine | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Neuropathy peripheral | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Neuropsychiatric lupus | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Optic neuritis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Subarachnoid haemorrhage | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Syncope | 0/937 (0%) | 0 | 2/578 (0.3%) | 3 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Tension headache | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Transient ischaemic attack | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| VIIth nerve paralysis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| VIth nerve disorder | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Abortion | 1/877 (0.1%) | 1 | 0/527 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Abortion spontaneous | 1/877 (0.1%) | 1 | 1/527 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Blighted ovum | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/760 (0%) | 0 | 1/482 (0.2%) | 1 |
| Ectopic pregnancy | 1/877 (0.1%) | 1 | 0/527 (0%) | 0 | 1/760 (0.1%) | 1 | 0/482 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Anxiety | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Conversion disorder | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Delirium tremens | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Depression | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Generalised anxiety disorder | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Mental status changes | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Suicide attempt | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Bladder prolapse | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Calculus ureteric | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Glomerulonephritis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Hydronephrosis | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Lupus nephritis | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 2/810 (0.2%) | 2 | 4/526 (0.8%) | 4 |
| Nephrolithiasis | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Renal failure acute | 2/937 (0.2%) | 3 | 2/578 (0.3%) | 2 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Urinary retention | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Reproductive system and breast disorders | ||||||||
| Benign prostatic hyperplasia | 0/60 (0%) | 0 | 1/51 (2%) | 1 | 0/50 (0%) | 0 | 1/44 (2.3%) | 1 |
| Dysmenorrhoea | 0/877 (0%) | 0 | 1/527 (0.2%) | 1 | 0/760 (0%) | 0 | 1/482 (0.2%) | 1 |
| Metrorrhagia | 1/877 (0.1%) | 1 | 0/527 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Ovarian cyst | 0/877 (0%) | 0 | 1/527 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Acute respiratory distress syndrome | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Acute respiratory failure | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Asthma | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 2/810 (0.2%) | 2 | 0/526 (0%) | 0 |
| Atelectasis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Chronic obstructive pulmonary disease | 4/937 (0.4%) | 4 | 0/578 (0%) | 0 | 3/810 (0.4%) | 3 | 0/526 (0%) | 0 |
| Dyspnoea | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Haemoptysis | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Hypoxia | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Interstitial lung disease | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Pleural effusion | 1/937 (0.1%) | 1 | 2/578 (0.3%) | 2 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pleural fibrosis | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pulmonary congestion | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Pulmonary embolism | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 2/810 (0.2%) | 2 | 0/526 (0%) | 0 |
| Pulmonary haemorrhage | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Pulmonary hypertension | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Pulmonary oedema | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Upper airway obstruction | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Angioedema | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Dry gangrene | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Mucocutaneous ulceration | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Precancerous skin lesion | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Psoriasis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Skin ulcer | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Vascular disorders | ||||||||
| Deep vein thrombosis | 2/937 (0.2%) | 2 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Extremity necrosis | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Hypertension | 4/937 (0.4%) | 4 | 0/578 (0%) | 0 | 4/810 (0.5%) | 4 | 0/526 (0%) | 0 |
| Hypotension | 1/937 (0.1%) | 3 | 1/578 (0.2%) | 1 | 1/810 (0.1%) | 1 | 1/526 (0.2%) | 1 |
| Infarction | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Orthostatic hypotension | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 2 | 0/526 (0%) | 0 |
| Peripheral arterial occlusive disease | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 1/810 (0.1%) | 1 | 0/526 (0%) | 0 |
| Poor venous access | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Shock haemorrhagic | 0/937 (0%) | 0 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Thrombophlebitis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Vasculitis | 1/937 (0.1%) | 1 | 0/578 (0%) | 0 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Venous occlusion | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
| Venous thrombosis limb | 0/937 (0%) | 0 | 1/578 (0.2%) | 1 | 0/810 (0%) | 0 | 1/526 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| LY 2127399 Q2W Treatment | LY2127399 Q4W Treatment | LY 2127399 Q2W Follow Up | LY2127399 Q4W Follow Up | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 464/937 (49.5%) | 232/578 (40.1%) | 37/810 (4.6%) | 24/526 (4.6%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 21/937 (2.2%) | 21 | 3/578 (0.5%) | 3 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Abdominal pain upper | 9/937 (1%) | 9 | 12/578 (2.1%) | 12 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Diarrhoea | 59/937 (6.3%) | 70 | 18/578 (3.1%) | 21 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Gastrooesophageal reflux disease | 23/937 (2.5%) | 24 | 7/578 (1.2%) | 7 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Nausea | 34/937 (3.6%) | 36 | 12/578 (2.1%) | 14 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Vomiting | 21/937 (2.2%) | 23 | 10/578 (1.7%) | 10 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| General disorders | ||||||||
| Fatigue | 19/937 (2%) | 20 | 7/578 (1.2%) | 7 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pyrexia | 20/937 (2.1%) | 25 | 4/578 (0.7%) | 4 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Infections and infestations | ||||||||
| Bronchitis | 57/937 (6.1%) | 74 | 26/578 (4.5%) | 32 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Gastroenteritis | 14/937 (1.5%) | 18 | 16/578 (2.8%) | 16 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Nasopharyngitis | 63/937 (6.7%) | 83 | 40/578 (6.9%) | 46 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pharyngitis | 27/937 (2.9%) | 33 | 15/578 (2.6%) | 16 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Sinusitis | 56/937 (6%) | 64 | 17/578 (2.9%) | 28 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Upper respiratory tract infection | 104/937 (11.1%) | 142 | 51/578 (8.8%) | 68 | 18/810 (2.2%) | 18 | 11/526 (2.1%) | 12 |
| Urinary tract infection | 106/937 (11.3%) | 158 | 52/578 (9%) | 78 | 20/810 (2.5%) | 21 | 16/526 (3%) | 18 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 33/937 (3.5%) | 39 | 12/578 (2.1%) | 16 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Back pain | 36/937 (3.8%) | 39 | 17/578 (2.9%) | 17 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Pain in extremity | 27/937 (2.9%) | 29 | 6/578 (1%) | 8 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Nervous system disorders | ||||||||
| Dizziness | 18/937 (1.9%) | 19 | 12/578 (2.1%) | 13 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Headache | 53/937 (5.7%) | 67 | 28/578 (4.8%) | 34 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Anxiety | 21/937 (2.2%) | 21 | 10/578 (1.7%) | 11 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Insomnia | 18/937 (1.9%) | 18 | 12/578 (2.1%) | 12 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 28/937 (3%) | 29 | 10/578 (1.7%) | 13 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Rash | 23/937 (2.5%) | 28 | 6/578 (1%) | 8 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
| Vascular disorders | ||||||||
| Hypertension | 27/937 (2.9%) | 27 | 8/578 (1.4%) | 10 | 0/810 (0%) | 0 | 0/526 (0%) | 0 |
Limitations/Caveats
Study terminated early due to lack of efficacy in parent studies.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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:
NCT01488708
Other Study ID Numbers:
- 13811
- H9B-MC-BCDX
First Posted:
Dec 8, 2011
Last Update Posted:
May 17, 2018
Last Verified:
May 1, 2018