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A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01205438
Collaborator
(none)
1,124
Enrollment
185
Locations
3
Arms
49.9
Duration (Months)
6.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY2127399 every 2 weeks

Drug: LY2127399
120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Experimental: LY2127399 every 4 weeks

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

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

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

Drug: Placebo every 2 weeks
Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants Achieving an SLE Responder Index Response at Week 52 [52 weeks]

    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.

Secondary Outcome Measures

  1. Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52 [52 weeks]

    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.

  2. Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level [Baseline, 52 weeks]

    Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.

  3. Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score [Baseline, 52 weeks]

    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.

  4. Time to First Severe SLE Flare (SFI) [Baseline through 52 weeks]

    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).

  5. Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA) [Baseline, 52 weeks]

    PGA is a single-item clinician rated assessment of the participant'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 defined as increase of ≤ 0.30 points from Baseline.

  6. Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores [Baseline, 52 weeks]

    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.

  7. Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks [52 weeks]

    Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the participant'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 are presented from 0 to 100.No worsening defined as increase of ≤ 0.30 points from Baseline.

  8. Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores [Baseline, 52 weeks]

    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).

  9. Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares [Baseline through 52 weeks]

    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.

  10. Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks [52 weeks]

    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.

  11. Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score [Baseline, 52 weeks]

    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.

  12. Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline [Baseline through 52 weeks]

    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.

  13. 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 [52 weeks]

    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. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria

  • Have positive antinuclear antibodies (ANA)

  • Agree not to become pregnant throughout the course of the trial

  • Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)

Exclusion Criteria:

  • Have active severe Lupus kidney disease

  • Have active Central Nervous System or peripheral neurologic disease

  • Have received intravenous immunoglobulin (IVIg) within 180 days of randomization

  • Have active or recent infection within 30 days of screening

  • Have had a serious infection within 90 days of randomization

  • Have evidence or test positive for Hepatitis B

  • Have Hepatitis C

  • Are human immunodeficiency virus (HIV) positive

  • Have evidence of active or latent tuberculosis (TB)

  • Presence of significant laboratory abnormalities at screening

  • Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization

  • Have received greater than 40 mgs of prednisone or equivalent in the past 30 days

  • Have changed your dose of antimalarial drug in the past 30 days

  • Have changed your dose of immunosuppressive drug in the past 90 days

  • Have previously received rituximab

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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Anniston Alabama United States 36207
2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Birmingham Alabama United States 35216
3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gilbert Arizona United States 85234
4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Scottsdale Arizona United States 85258
5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tempe Arizona United States 85282
6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Malvern Arkansas United States 72104
7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Covina California United States 91723
8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. El Cajon California United States 92020
9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Escondido California United States 92027
10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. La Mesa California United States 91941
11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lakewood California United States 90712
12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Los Alamitos California United States 90720
13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Los Angeles California United States 90095
14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pasadena California United States 91107
15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Riverside California United States 92506
16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Diego California United States 92108
17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Gabriel California United States 91776
18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Santa Barbara California United States 93108
19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Van Nuys California United States 91405
20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Westlake Village California United States 91361
21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Whittier California United States 90606
22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aurora Colorado United States 80045
23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Washington District of Columbia United States 20060
24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aventura Florida United States 33180
25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. DeBary Florida United States 32713
26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Miami Florida United States 33175
27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Naples Florida United States 34102
28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New Port Richey Florida United States 34652
29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ormond Beach Florida United States 32174
30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pensacola Florida United States 32514
31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pinellas Park Florida United States 33781
32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Plantation Florida United States 33324
33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. South Miami Florida United States 33143
34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tampa Florida United States 33603
35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vero Beach Florida United States 32960
36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Atlanta Georgia United States 30303
37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Duluth Georgia United States 30096
38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lithonia Georgia United States 30038
39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Meridian Idaho United States 83642
40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chicago Illinois United States 60612
41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rockford Illinois United States 61107
42 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fort Wayne Indiana United States 46804
43 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Granger Indiana United States 46530
44 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Indianapolis Indiana United States 46202
45 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Monroe Louisiana United States 71203
46 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Portland Maine United States 04102
47 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cumberland Maryland United States 21502
48 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Clair Shores Michigan United States 48081
49 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Duluth Minnesota United States 55805
50 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hattiesburg Mississippi United States 39402
51 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Louis Missouri United States 63117
52 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Las Vegas Nevada United States 89128
53 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nashua New Hampshire United States 03060
54 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Freehold New Jersey United States 07728
55 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Voorhees New Jersey United States 08043
56 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Las Cruces New Mexico United States 88011
57 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Albany New York United States 12206
58 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brooklyn New York United States 11201
59 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Manhasset New York United States 11030
60 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New York New York United States 10016
61 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New York New York United States 10021
62 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Plainview New York United States 11803
63 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Roslyn New York United States 11576
64 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chapel Hill North Carolina United States 27599
65 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Charlotte North Carolina United States 28204
66 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Raleigh North Carolina United States 27617
67 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rocky Mount North Carolina United States 27804
68 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cincinnati Ohio United States 45219
69 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cleveland Ohio United States 44109
70 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Toledo Ohio United States 43606
71 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Oklahoma City Oklahoma United States 73104
72 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Duncansville Pennsylvania United States 16635
73 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wyomissing Pennsylvania United States 19610
74 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Charleston South Carolina United States 29425
75 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cookeville Tennessee United States 38501
76 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Knoxville Tennessee United States 37909
77 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Memphis Tennessee United States 38163
78 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nashville Tennessee United States 37203
79 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Amarillo Texas United States 79124
80 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Austin Texas United States 78745
81 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nassau Bay Texas United States 77058
82 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Round Rock Texas United States 78665
83 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Antonio Texas United States 78232
84 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Victoria Texas United States 77901
85 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint George Utah United States 84790
86 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seattle Washington United States 98104
87 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Spokane Washington United States 99204
88 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Clarksburg West Virginia United States 26301
89 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. St Leonards New South Wales Australia 2065
90 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cairns Queensland Australia 4870
91 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Maroochydore Queensland Australia 4558
92 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Clayton Victoria Australia 3168
93 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Heidelberg Victoria Australia 3081
94 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Malvern East Australia 3145
95 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Campinas Brazil 13015-011
96 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Goiania Brazil 74110-120
97 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Juiz De Fora Brazil 36010-570
98 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Porto Alegre Brazil 91350-200
99 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Salvador Brazil 40050-410
100 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. São Paulo Brazil 04039-901
101 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hamilton Ontario Canada L8N 3Z5
102 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Trois-Rivieres Quebec Canada G8Z 1Y2
103 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cuenca Ecuador EC010150
104 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Guayaquil Ecuador 90110321
105 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Quito Ecuador 17
106 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Orleans France 45000
107 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Strasbourg France 67091
108 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Budapest Hungary 1027
109 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Debrecen Hungary 4032
110 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gyor Hungary 9023
111 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gyula Hungary 5700
112 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Szeged Hungary 6720
113 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bangalore India 560043
114 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gujarat India 380015
115 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Haryana India 122001
116 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hyderabaad India 500082
117 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kormangala India 560034
118 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pune India 411007
119 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Trivandrum India 695011
120 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Haifa Israel 34362
121 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kfar Saba Israel 44281
122 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Petah Tikva Israel 49100
123 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tel Hashomer Israel 52651
124 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zerifin Israel 70300
125 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Riga Latvia LV-1002
126 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kota Kinabalu Malaysia 88586
127 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kuala Lumpur Malaysia 59100
128 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Guadalajara Mexico 44650
129 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Merida Mexico 97130
130 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mexico City Mexico 06090
131 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Luis Potosi Mexico 78200
132 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Luis Mexico 78240
133 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tijuana Mexico 22010
134 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hamilton New Zealand 3204
135 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Otahuhu New Zealand 1640
136 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Takapuna New Zealand 622
137 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brasov Romania 500283
138 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bucharest Romania 020475
139 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cluj-Napoca Romania 400006
140 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Galati Romania 800587
141 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Iasi Romania 700656
142 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Targu Mures Romania 540136
143 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chelyabinsk Russian Federation 454076
144 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ekaterinburg Russian Federation 620012
145 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kazan Russian Federation 420097
146 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kemerovo Russian Federation 650099
147 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Moscow Russian Federation 125101
148 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Orenburg Russian Federation 460018
149 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Petersburg Russian Federation 197089
150 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tomsk Russian Federation 634063
151 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Yaroslavl Russian Federation 150023
152 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Belgrade Serbia 11000
153 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kragujevac Serbia 34000
154 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Niska Banja Serbia 18205
155 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Novi Sad Serbia 21000
156 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cape Town South Africa 7925
157 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Durban South Africa 4001
158 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Stellenbosch South Africa 7600
159 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Barcelona Spain 08035
160 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bilbao Spain 48013
161 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. La Coruña Spain 15006
162 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Las Palmas De Gran Canaria Spain 35010
163 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Madrid Spain 28040
164 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Málaga Spain 29010
165 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Santiago De Compostela Spain 15706
166 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sevilla Spain 41071
167 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vigo Spain 36200
168 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Changhua Taiwan 500
169 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hualien Taiwan 970
170 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kaohsiung Taiwan 833
171 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taichung City Taiwan 40201
172 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taichung Taiwan 40705
173 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taipei Taiwan 10630
174 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. La Marsa Tunisia 2070
175 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Monastir Tunisia 5000
176 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sfax Tunisia 3029
177 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sousse Tunisia 4000
178 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tunis Monfleury Tunisia 1008
179 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tunis Tunisia 1008
180 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cambridge Cambridgeshire United Kingdom CB2 0QQ
181 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Poole Dorset United Kingdom BH15 2JB
182 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. London Greater London United Kingdom E11 1NR
183 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Maidstone Kent United Kingdom ME16 9QQ
184 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wigan Lancashire United Kingdom WN6 0LW
185 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. London United Kingdom SE1 7EH

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 9AM - 5PM 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:
NCT01205438
Other Study ID Numbers:
  • 13653
  • H9B-MC-BCDT
First Posted:
Sep 20, 2010
Last Update Posted:
Jul 17, 2018
Last Verified:
Jun 1, 2018
Keywords provided by Eli Lilly and Company
SLE
Systemic Lupus Erythematosis
Lupus
autoimmune disease
LY2127399
Immune System Disease
Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks Placebo
Arm/Group Description 120mg LY2127399 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. 120mg LY2127399 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 372 376 376
Received At Least One Dose of Study Drug 371 374 376
Participated in Follow Up 72 78 66
COMPLETED 295 289 288
NOT COMPLETED 77 87 88

Baseline Characteristics

Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks Placebo Total
Arm/Group Description 120mg LY2127399 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. 120mg LY2127399 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 Participants 372 376 376 1124
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
42.3
(12.41)
41.2
(12.73)
41.9
(12.08)
41.8
(12.40)
Sex: Female, Male (Count of Participants)
Female
342
91.9%
346
92%
349
92.8%
1037
92.3%
Male
30
8.1%
30
8%
27
7.2%
87
7.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
110
29.6%
92
24.5%
99
26.3%
301
26.8%
Not Hispanic or Latino
229
61.6%
233
62%
235
62.5%
697
62%
Unknown or Not Reported
33
8.9%
51
13.6%
42
11.2%
126
11.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
31
8.3%
33
8.8%
30
8%
94
8.4%
Asian
38
10.2%
34
9%
40
10.6%
112
10%
Native Hawaiian or Other Pacific Islander
1
0.3%
2
0.5%
0
0%
3
0.3%
Black or African American
43
11.6%
46
12.2%
51
13.6%
140
12.5%
White
245
65.9%
247
65.7%
249
66.2%
741
65.9%
More than one race
14
3.8%
14
3.7%
6
1.6%
34
3%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (Count of Participants)
Ecuador
20
5.4%
17
4.5%
12
3.2%
49
4.4%
Russia
12
3.2%
19
5.1%
12
3.2%
43
3.8%
Romania
9
2.4%
8
2.1%
13
3.5%
30
2.7%
Hungary
18
4.8%
17
4.5%
18
4.8%
53
4.7%
United States
143
38.4%
137
36.4%
148
39.4%
428
38.1%
United Kingdom
3
0.8%
3
0.8%
3
0.8%
9
0.8%
Malaysia
2
0.5%
1
0.3%
4
1.1%
7
0.6%
India
11
3%
13
3.5%
16
4.3%
40
3.6%
Spain
9
2.4%
12
3.2%
9
2.4%
30
2.7%
New Zealand
3
0.8%
4
1.1%
1
0.3%
8
0.7%
Canada
3
0.8%
3
0.8%
2
0.5%
8
0.7%
Latvia
3
0.8%
4
1.1%
2
0.5%
9
0.8%
Taiwan
20
5.4%
14
3.7%
16
4.3%
50
4.4%
Brazil
23
6.2%
25
6.6%
22
5.9%
70
6.2%
Mexico
19
5.1%
22
5.9%
23
6.1%
64
5.7%
South Africa
14
3.8%
17
4.5%
7
1.9%
38
3.4%
Israel
9
2.4%
7
1.9%
12
3.2%
28
2.5%
Serbia
19
5.1%
25
6.6%
32
8.5%
76
6.8%
Australia
9
2.4%
7
1.9%
3
0.8%
19
1.7%
France
2
0.5%
1
0.3%
1
0.3%
4
0.4%
Tunisia
21
5.6%
20
5.3%
20
5.3%
61
5.4%
Anti-dsDNA Antibody Level (International Unit / Milliliter (IU/mL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [International Unit / Milliliter (IU/mL)]
116.8
(118.17)
110.6
(113.51)
112.0
(116.60)
113.1
(116.03)
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]
10.4
(4.07)
10.4
(4.17)
9.8
(3.28)
10.2
(3.86)
Physician's Global Assessment (PGA) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
47.2
(15.45)
46.8
(15.60)
44.9
(16.57)
46.3
(15.90)
At Least One BILAG A or Two BILAG B Disease Activity Scores (Count of Participants)
Count of Participants [Participants]
230
61.8%
218
58%
209
55.6%
657
58.5%
Time of Onset of Lupus (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
8.36
(8.500)
7.94
(7.615)
7.74
(7.078)
8.01
(7.748)
Lupus Quality of Life (LupusQOL) Domain Scores (units on a scale) [Mean (Standard Deviation) ]
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)
Brief Fatigue Inventory (BFI) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
5.8
(2.57)
5.6
(2.81)
5.6
(2.81)
5.6
(2.73)

Outcome Measures

1. Primary Outcome
Title Percentage of Participants Achieving an SLE Responder Index Response at Week 52
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

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 372 376 376
Number [percentage of participants]
38.5
10.3%
34.8
9.3%
27.7
7.4%
2. Secondary Outcome
Title Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
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.
Time Frame 52 weeks

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 146 129 131
Number [percentage of participants]
21.2
5.7%
14.7
3.9%
11.5
3.1%
3. Secondary Outcome
Title Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level
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

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), Last observation carried (LOCF). LOCF 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 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 368 372 372
Mean (Standard Deviation) [International Units (IU)]
-27.7
(65.31)
-26.4
(64.13)
-7.0
(56.53)
4. Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score
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

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), Last observation carried (LOCF). LOCF 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 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 372 376 376
Baseline
10.3
(4.17)
10.4
(4.01)
9.8
(3.36)
52 Weeks
-4.9
(4.57)
-4.7
(4.62)
-3.6
(4.21)
5. Secondary Outcome
Title Time to First Severe SLE Flare (SFI)
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

Outcome Measure Data

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 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 0 0 0
6. Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)
Description PGA is a single-item clinician rated assessment of the participant'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 defined as increase of ≤ 0.30 points from Baseline.
Time Frame Baseline, 52 weeks

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), Last observation carried (LOCF). LOCF 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 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 372 376 376
Mean (Standard Deviation) [units on a scale]
-21.2
(21.28)
-19.2
(23.13)
-15.1
(23.52)
7. Secondary Outcome
Title Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
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

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 372 376 376
Physical Health
69.0
(26.42)
66.2
(28.01)
70.7
(27.78)
Emotional Health
72.7
(27.03)
72.3
(27.72)
74.0
(28.85)
Body Image
73.6
(27.79)
72.8
(27.60)
73.1
(29.76)
Pain
68.5
(28.98)
67.5
(29.78)
71.4
(29.80)
Planning
71.0
(30.04)
70.7
(31.71)
73.2
(33.39)
Fatigue
65.5
(26.23)
62.4
(28.17)
69.3
(26.27)
Intimate Relationships
68.4
(33.39)
66.1
(33.81)
72.4
(31.42)
Burden to Others
62.6
(32.89)
63.7
(31.06)
69.2
(31.33)
8. Secondary Outcome
Title Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
Description Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the participant'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 are presented from 0 to 100.No worsening defined as increase of ≤ 0.30 points from Baseline.
Time Frame 52 weeks

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 372 376 376
Number [percentage of participants]
32.8
8.8%
37.8
10.1%
42.8
11.4%
9. Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores
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

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), Last observation carried (LOCF). LOCF 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 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 358 352 354
Mean (Standard Deviation) [units on a scale]
-0.7
(3.09)
-0.5
(2.91)
-0.5
(2.95)
10. Secondary Outcome
Title Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares
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

Outcome Measure Data

Analysis Population Description
Zero participants analyzed. Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE flare data was not collected for analysis.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 0 0 0
11. Secondary Outcome
Title Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks
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

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), only participants receiving a prednisone or equivalent dose of more than 2.5 mg/day at baseline are included.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 295 289 288
Number [percentage of participants]
4.7
1.3%
6.2
1.6%
5.9
1.6%
12. Secondary Outcome
Title Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score
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

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), Last observation carried (LOCF). LOCF 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 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 368 367 372
Mean (Standard Deviation) [units on a scale]
-5.1
(4.62)
-4.8
(4.69)
-3.7
(4.31)
13. 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
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 Frame Baseline through 52 weeks

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), all randomized participants who received at least one dose of study drug.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 371 374 376
Count of Participants [Participants]
134
36%
144
38.3%
160
42.6%
14. 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
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. 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

Outcome Measure Data

Analysis Population Description
Intention to treat (ITT), all randomized participants who received at least one dose of study drug. Non-responder imputation (NRI) included.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks Placebo
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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.
Measure Participants 372 376 376
Number [percentage of participants]
38.7
10.4%
34.8
9.3%
27.7
7.4%

Adverse Events

Time Frame
Adverse Event Reporting Description All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
Arm/Group Title LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks Placebo LY2127399 Every 2 Weeks, Follow Up LY2127399 Every 4 Wks, Follow Up Placebo, Follow Up
Arm/Group Description LY2127399: 120mg 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, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120mg 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 for participants receiving LY2127399 every 2 weeks during the Treatment Period. 24-48 weeks post last dose for participants receiving LY2127399 every 4 weeks during the Treatment Period. 24-48 weeks post last dose for participants receiving placebo during the Treatment Period.
All Cause Mortality
LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks 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 / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks 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 46/371 (12.4%) 59/374 (15.8%) 70/376 (18.6%) 8/72 (11.1%) 12/78 (15.4%) 14/66 (21.2%)
Blood and lymphatic system disorders
Anaemia 0/371 (0%) 0 1/374 (0.3%) 1 2/376 (0.5%) 2 0/72 (0%) 0 1/78 (1.3%) 1 1/66 (1.5%) 1
Disseminated intravascular coagulation 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Haemolytic anaemia 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Immune thrombocytopenic purpura 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Iron deficiency anaemia 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Leukocytosis 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 1/66 (1.5%) 1
Leukopenia 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pancytopenia 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Thrombocytopenia 0/371 (0%) 0 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 1/78 (1.3%) 2 0/66 (0%) 0
Cardiac disorders
Acute coronary syndrome 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Acute myocardial infarction 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Angina unstable 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Bradycardia 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Cardiac failure 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Cardiac failure congestive 1/371 (0.3%) 1 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 1/78 (1.3%) 1 1/66 (1.5%) 1
Cardiopulmonary failure 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Coronary artery disease 0/371 (0%) 0 0/374 (0%) 0 4/376 (1.1%) 4 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Left ventricular failure 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Myocardial infarction 0/371 (0%) 0 2/374 (0.5%) 2 0/376 (0%) 0 1/72 (1.4%) 1 1/78 (1.3%) 1 0/66 (0%) 0
Pericardial effusion 0/371 (0%) 0 2/374 (0.5%) 2 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pericarditis 1/371 (0.3%) 1 1/374 (0.3%) 2 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Ventricular tachycardia 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Ear and labyrinth disorders
Vertigo positional 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Endocrine disorders
Addison's disease 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Eye disorders
Accommodation disorder 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Gastrointestinal disorders
Abdominal pain 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Diarrhoea 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Duodenitis 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Food poisoning 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Gastritis 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Gastritis erosive 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Gastrooesophageal reflux disease 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Haematochezia 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Haemorrhoids 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pancreatitis acute 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Proctitis 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Rectal haemorrhage 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Retroperitoneal haemorrhage 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Small intestinal obstruction 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Small intestinal perforation 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Upper gastrointestinal haemorrhage 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
General disorders
Asthenia 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Chest discomfort 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Non-cardiac chest pain 2/371 (0.5%) 2 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Oedema 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pyrexia 1/371 (0.3%) 1 1/374 (0.3%) 1 2/376 (0.5%) 2 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Serositis 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Hepatobiliary disorders
Cholangitis acute 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Cholecystitis 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Cholecystitis acute 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Cholelithiasis 0/371 (0%) 0 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Lupus hepatitis 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Infections and infestations
Abdominal abscess 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Appendicitis 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Atypical pneumonia 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Bronchitis 0/371 (0%) 0 2/374 (0.5%) 2 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Bronchopneumonia 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Cellulitis 2/371 (0.5%) 2 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Cellulitis staphylococcal 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Clostridium difficile colitis 1/371 (0.3%) 1 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Clostridium difficile infection 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Diverticulitis 2/371 (0.5%) 2 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Endocarditis 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Epstein-Barr virus infection 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Erysipelas 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Gastroenteritis 1/371 (0.3%) 1 1/374 (0.3%) 1 2/376 (0.5%) 2 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Gastroenteritis salmonella 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Gastroenteritis viral 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Herpes simplex 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Herpes zoster 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 2/66 (3%) 2
Infectious mononucleosis 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 1/72 (1.4%) 1 0/78 (0%) 0 0/66 (0%) 0
Influenza 0/371 (0%) 0 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Lobar pneumonia 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Lower respiratory tract infection 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Lung infection 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Ophthalmic herpes zoster 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Otitis media acute 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Perinephric abscess 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 1/72 (1.4%) 1 0/78 (0%) 0 0/66 (0%) 0
Perirectal abscess 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pneumonia 4/371 (1.1%) 4 2/374 (0.5%) 2 7/376 (1.9%) 7 1/72 (1.4%) 1 0/78 (0%) 0 0/66 (0%) 0
Pneumonia haemophilus 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pneumonia mycoplasmal 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pneumonia pneumococcal 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Post procedural infection 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 1/72 (1.4%) 1 0/78 (0%) 0 0/66 (0%) 0
Pulmonary tuberculosis 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Pyelonephritis acute 0/371 (0%) 0 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Salmonella bacteraemia 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Sepsis 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Sepsis syndrome 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Septic arthritis staphylococcal 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Septic shock 0/371 (0%) 0 2/374 (0.5%) 2 1/376 (0.3%) 1 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Sinusitis 0/371 (0%) 0 2/374 (0.5%) 2 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Staphylococcal bacteraemia 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Staphylococcal skin infection 0/371 (0%) 0 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Tracheobronchitis 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Upper respiratory tract infection 0/371 (0%) 0 0/374 (0%) 0 2/376 (0.5%) 2 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Urinary tract infection 1/371 (0.3%) 1 2/374 (0.5%) 2 2/376 (0.5%) 2 0/72 (0%) 0 1/78 (1.3%) 1 1/66 (1.5%) 1
Viral diarrhoea 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Viral infection 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 1/72 (1.4%) 1 0/78 (0%) 0 0/66 (0%) 0
Wound infection 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Injury, poisoning and procedural complications
Accident 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Animal bite 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Ankle fracture 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Contusion 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Fall 1/371 (0.3%) 1 0/374 (0%) 0 2/376 (0.5%) 2 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Femoral neck fracture 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Femur fracture 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Gastrointestinal injury 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Hip fracture 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Lumbar vertebral fracture 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Multiple injuries 1/371 (0.3%) 1 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Overdose 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Road traffic accident 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Stab wound 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Upper limb fracture 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Wound 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Investigations
Haemoglobin decreased 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Weight decreased 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Metabolism and nutrition disorders
Dehydration 0/371 (0%) 0 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Hyperglycaemia 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Hyperkalaemia 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Hypoglycaemia 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Type 2 diabetes mellitus 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Musculoskeletal and connective tissue disorders
Back pain 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Bursitis 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Fibromyalgia 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Lumbar spinal stenosis 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Osteoarthritis 2/371 (0.5%) 2 0/374 (0%) 0 2/376 (0.5%) 2 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Osteonecrosis 0/371 (0%) 0 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Polyarthritis 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Rheumatoid arthritis 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Spondylolisthesis 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Synovitis 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Systemic lupus erythematosus 3/371 (0.8%) 3 4/374 (1.1%) 4 6/376 (1.6%) 7 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Lung adenocarcinoma 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Papillary thyroid cancer 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Squamous cell carcinoma of the vagina 0/341 (0%) 0 1/344 (0.3%) 1 0/349 (0%) 0 0/67 (0%) 0 1/74 (1.4%) 1 0/63 (0%) 0
Uterine leiomyoma 0/341 (0%) 0 0/344 (0%) 0 2/349 (0.6%) 2 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Nervous system disorders
Brain oedema 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Cerebral infarction 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Convulsion 0/371 (0%) 0 1/374 (0.3%) 1 2/376 (0.5%) 2 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Dizziness 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Haemorrhage intracranial 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Headache 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Hypoaesthesia 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Lacunar infarction 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Nervous system disorder 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Syncope 0/371 (0%) 0 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Transient ischaemic attack 1/371 (0.3%) 1 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Vasculitis cerebral 0/371 (0%) 0 0/374 (0%) 0 2/376 (0.5%) 2 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/67 (0%) 0 0/74 (0%) 0 1/63 (1.6%) 1
Psychiatric disorders
Anxiety 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Anxiety disorder 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Bipolar disorder 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Borderline personality disorder 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Completed suicide 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Depression 1/371 (0.3%) 1 1/374 (0.3%) 1 0/376 (0%) 0 1/72 (1.4%) 1 0/78 (0%) 0 0/66 (0%) 0
Dysthymic disorder 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Hallucination 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Intentional self-injury 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Major depression 0/371 (0%) 0 2/374 (0.5%) 2 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Neurosis 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Panic attack 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Psychotic disorder 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Substance-induced psychotic disorder 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Suicidal ideation 0/371 (0%) 0 2/374 (0.5%) 2 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Suicide attempt 0/371 (0%) 0 2/374 (0.5%) 2 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Renal and urinary disorders
Calculus urinary 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 1/72 (1.4%) 1 0/78 (0%) 0 0/66 (0%) 0
Glomerulonephritis 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Hydronephrosis 2/371 (0.5%) 2 0/374 (0%) 0 0/376 (0%) 0 1/72 (1.4%) 1 0/78 (0%) 0 0/66 (0%) 0
Lupus nephritis 2/371 (0.5%) 2 2/374 (0.5%) 2 2/376 (0.5%) 2 1/72 (1.4%) 1 0/78 (0%) 0 1/66 (1.5%) 1
Nephropathy 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Nephrotic syndrome 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Obstructive uropathy 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Proteinuria 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Renal failure acute 2/371 (0.5%) 2 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Renal mass 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Urethral polyp 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Reproductive system and breast disorders
Cervical dysplasia 0/341 (0%) 0 0/344 (0%) 0 1/349 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Endometrial hyperplasia 1/341 (0.3%) 1 0/344 (0%) 0 0/349 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Menometrorrhagia 0/341 (0%) 0 0/344 (0%) 0 1/349 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Menorrhagia 0/341 (0%) 0 0/344 (0%) 0 1/349 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Ovarian cyst ruptured 1/341 (0.3%) 1 0/344 (0%) 0 0/349 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Uterine haemorrhage 1/341 (0.3%) 1 0/344 (0%) 0 0/349 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Asthma 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Chronic obstructive pulmonary disease 0/371 (0%) 0 1/374 (0.3%) 1 2/376 (0.5%) 2 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Dyspnoea 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Interstitial lung disease 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Lupus pneumonitis 0/371 (0%) 0 2/374 (0.5%) 2 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pleural effusion 0/371 (0%) 0 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pleurisy 1/371 (0.3%) 1 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Pleuritic pain 1/371 (0.3%) 1 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Pneumothorax 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pulmonary arterial hypertension 0/371 (0%) 0 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Pulmonary embolism 1/371 (0.3%) 1 2/374 (0.5%) 2 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pulmonary hypertension 1/371 (0.3%) 1 1/374 (0.3%) 1 1/376 (0.3%) 1 0/72 (0%) 0 1/78 (1.3%) 1 0/66 (0%) 0
Pulmonary oedema 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Respiratory failure 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Shrinking lung syndrome 0/371 (0%) 0 1/374 (0.3%) 2 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Skin and subcutaneous tissue disorders
Butterfly rash 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 1/66 (1.5%) 1
Cutaneous vasculitis 1/371 (0.3%) 1 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Surgical and medical procedures
Female sterilisation 1/341 (0.3%) 1 0/344 (0%) 0 0/349 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Vascular disorders
Accelerated hypertension 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Deep vein thrombosis 0/371 (0%) 0 3/374 (0.8%) 3 1/376 (0.3%) 1 0/72 (0%) 0 1/78 (1.3%) 1 1/66 (1.5%) 1
Femoral artery occlusion 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Hypertension 0/371 (0%) 0 1/374 (0.3%) 1 0/376 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Peripheral artery aneurysm 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Raynaud's phenomenon 1/371 (0.3%) 1 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Vasculitis 0/371 (0%) 0 0/374 (0%) 0 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Other (Not Including Serious) Adverse Events
LY2127399 Every 2 Weeks LY2127399 Every 4 Weeks 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 249/371 (67.1%) 239/374 (63.9%) 246/376 (65.4%) 16/72 (22.2%) 15/78 (19.2%) 13/66 (19.7%)
Blood and lymphatic system disorders
Leukopenia 8/371 (2.2%) 8 4/374 (1.1%) 8 3/376 (0.8%) 3 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Gastrointestinal disorders
Abdominal pain 7/371 (1.9%) 7 8/374 (2.1%) 8 9/376 (2.4%) 12 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Abdominal pain upper 11/371 (3%) 16 13/374 (3.5%) 13 8/376 (2.1%) 9 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Constipation 6/371 (1.6%) 6 9/374 (2.4%) 9 11/376 (2.9%) 13 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Diarrhoea 25/371 (6.7%) 29 21/374 (5.6%) 30 32/376 (8.5%) 37 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Dyspepsia 11/371 (3%) 14 5/374 (1.3%) 7 13/376 (3.5%) 16 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Gastrooesophageal reflux disease 7/371 (1.9%) 8 7/374 (1.9%) 7 8/376 (2.1%) 8 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Nausea 23/371 (6.2%) 25 21/374 (5.6%) 24 35/376 (9.3%) 42 1/72 (1.4%) 1 3/78 (3.8%) 3 0/66 (0%) 0
Toothache 9/371 (2.4%) 10 3/374 (0.8%) 3 3/376 (0.8%) 3 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Vomiting 17/371 (4.6%) 21 9/374 (2.4%) 12 17/376 (4.5%) 20 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
General disorders
Asthenia 8/371 (2.2%) 9 2/374 (0.5%) 3 3/376 (0.8%) 4 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Chest pain 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 2/72 (2.8%) 2 0/78 (0%) 0 0/66 (0%) 0
Fatigue 11/371 (3%) 18 5/374 (1.3%) 7 12/376 (3.2%) 18 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Injection site erythema 13/371 (3.5%) 16 6/374 (1.6%) 13 4/376 (1.1%) 8 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Injection site pain 9/371 (2.4%) 11 5/374 (1.3%) 14 5/376 (1.3%) 14 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Injection site reaction 9/371 (2.4%) 35 13/374 (3.5%) 20 4/376 (1.1%) 4 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Oedema peripheral 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 1/78 (1.3%) 2 2/66 (3%) 2
Pyrexia 7/371 (1.9%) 9 9/374 (2.4%) 11 8/376 (2.1%) 10 0/72 (0%) 0 0/78 (0%) 0 3/66 (4.5%) 3
Infections and infestations
Bronchitis 18/371 (4.9%) 22 25/374 (6.7%) 29 22/376 (5.9%) 28 0/72 (0%) 0 2/78 (2.6%) 2 0/66 (0%) 0
Cellulitis 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 0/72 (0%) 0 2/78 (2.6%) 2 1/66 (1.5%) 1
Conjunctivitis 4/371 (1.1%) 4 8/374 (2.1%) 8 6/376 (1.6%) 6 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Cystitis 7/371 (1.9%) 9 12/374 (3.2%) 14 4/376 (1.1%) 4 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Gastroenteritis 10/371 (2.7%) 14 10/374 (2.7%) 10 13/376 (3.5%) 14 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Gastroenteritis viral 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 2/72 (2.8%) 2 0/78 (0%) 0 1/66 (1.5%) 1
Herpes zoster 6/371 (1.6%) 7 10/374 (2.7%) 10 6/376 (1.6%) 6 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Influenza 12/371 (3.2%) 15 17/374 (4.5%) 20 6/376 (1.6%) 7 0/72 (0%) 0 1/78 (1.3%) 2 2/66 (3%) 2
Lower respiratory tract infection 9/371 (2.4%) 12 1/374 (0.3%) 1 3/376 (0.8%) 4 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Nasopharyngitis 24/371 (6.5%) 28 18/374 (4.8%) 22 32/376 (8.5%) 41 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Oral herpes 4/371 (1.1%) 5 10/374 (2.7%) 14 5/376 (1.3%) 7 2/72 (2.8%) 2 0/78 (0%) 0 1/66 (1.5%) 1
Pharyngitis 11/371 (3%) 12 9/374 (2.4%) 9 18/376 (4.8%) 18 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Sinusitis 26/371 (7%) 26 27/374 (7.2%) 30 19/376 (5.1%) 23 2/72 (2.8%) 2 1/78 (1.3%) 1 1/66 (1.5%) 1
Tooth abscess 1/371 (0.3%) 1 5/374 (1.3%) 6 8/376 (2.1%) 8 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Upper respiratory tract infection 58/371 (15.6%) 74 44/374 (11.8%) 60 45/376 (12%) 63 2/72 (2.8%) 2 1/78 (1.3%) 1 0/66 (0%) 0
Urinary tract infection 53/371 (14.3%) 80 60/374 (16%) 81 63/376 (16.8%) 86 4/72 (5.6%) 6 3/78 (3.8%) 3 3/66 (4.5%) 4
Vaginal infection 7/341 (2.1%) 9 5/344 (1.5%) 7 2/349 (0.6%) 2 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Viral upper respiratory tract infection 9/371 (2.4%) 9 2/374 (0.5%) 2 6/376 (1.6%) 8 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Injury, poisoning and procedural complications
Contusion 11/371 (3%) 13 5/374 (1.3%) 7 9/376 (2.4%) 18 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Fall 6/371 (1.6%) 6 2/374 (0.5%) 2 9/376 (2.4%) 10 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Investigations
Hepatic enzyme increased 8/371 (2.2%) 8 2/374 (0.5%) 2 3/376 (0.8%) 3 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Metabolism and nutrition disorders
Hypokalaemia 8/371 (2.2%) 10 8/374 (2.1%) 8 1/376 (0.3%) 1 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Musculoskeletal and connective tissue disorders
Arthralgia 18/371 (4.9%) 21 15/374 (4%) 16 15/376 (4%) 18 0/72 (0%) 0 2/78 (2.6%) 2 0/66 (0%) 0
Back pain 26/371 (7%) 27 21/374 (5.6%) 27 17/376 (4.5%) 20 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Bursitis 4/371 (1.1%) 4 9/374 (2.4%) 9 2/376 (0.5%) 2 1/72 (1.4%) 1 2/78 (2.6%) 3 0/66 (0%) 0
Musculoskeletal chest pain 18/371 (4.9%) 19 12/374 (3.2%) 14 9/376 (2.4%) 9 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Myalgia 7/371 (1.9%) 8 9/374 (2.4%) 9 10/376 (2.7%) 10 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pain in extremity 8/371 (2.2%) 8 10/374 (2.7%) 10 3/376 (0.8%) 5 0/72 (0%) 0 1/78 (1.3%) 1 2/66 (3%) 2
Nervous system disorders
Dizziness 8/371 (2.2%) 8 11/374 (2.9%) 11 12/376 (3.2%) 12 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Headache 34/371 (9.2%) 47 37/374 (9.9%) 50 34/376 (9%) 52 2/72 (2.8%) 2 1/78 (1.3%) 1 0/66 (0%) 0
Migraine 8/371 (2.2%) 8 14/374 (3.7%) 17 8/376 (2.1%) 9 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Pregnancy, puerperium and perinatal conditions
Pregnancy 0/371 (0%) 0 0/374 (0%) 0 0/376 (0%) 0 1/67 (1.5%) 1 0/74 (0%) 0 2/63 (3.2%) 2
Psychiatric disorders
Anxiety 14/371 (3.8%) 15 11/374 (2.9%) 11 12/376 (3.2%) 12 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Depression 14/371 (3.8%) 14 17/374 (4.5%) 18 3/376 (0.8%) 3 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Insomnia 13/371 (3.5%) 13 21/374 (5.6%) 22 15/376 (4%) 18 0/72 (0%) 0 3/78 (3.8%) 3 1/66 (1.5%) 1
Reproductive system and breast disorders
Penis disorder 1/30 (3.3%) 1 0/30 (0%) 0 0/27 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Prostatomegaly 1/30 (3.3%) 1 0/30 (0%) 0 0/27 (0%) 0 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Respiratory, thoracic and mediastinal disorders
Cough 17/371 (4.6%) 18 14/374 (3.7%) 14 17/376 (4.5%) 18 2/72 (2.8%) 2 0/78 (0%) 0 1/66 (1.5%) 1
Oropharyngeal pain 9/371 (2.4%) 10 10/374 (2.7%) 12 5/376 (1.3%) 5 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Skin and subcutaneous tissue disorders
Pruritus 5/371 (1.3%) 5 10/374 (2.7%) 11 7/376 (1.9%) 7 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Rash 8/371 (2.2%) 12 7/374 (1.9%) 7 8/376 (2.1%) 12 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0
Vascular disorders
Hypertension 17/371 (4.6%) 17 8/374 (2.1%) 10 16/376 (4.3%) 16 0/72 (0%) 0 0/78 (0%) 0 0/66 (0%) 0

Limitations/Caveats

Due to product program termination, not all analyses were completed.

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
Email
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01205438
Other Study ID Numbers:
  • 13653
  • H9B-MC-BCDT
First Posted:
Sep 20, 2010
Last Update Posted:
Jul 17, 2018
Last Verified:
Jun 1, 2018