Trial Outcomes & Findings for A Study of LY2127399 in Participants With Systemic Lupus Erythematosus (NCT NCT01196091)
NCT ID: NCT01196091
Last Updated: 2018-06-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1164 participants
Primary outcome timeframe
52 weeks
Results posted on
2018-06-12
Participant Flow
Intent to Treat population (ITT) is all randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.
Participant milestones
| Measure |
LY2127399 Every 2 Weeks
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Overall Study
STARTED
|
387
|
389
|
388
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
386
|
389
|
387
|
|
Overall Study
ITT-Received Drug and Excluded Sites
|
381
|
378
|
379
|
|
Overall Study
Follow-Up
|
103
|
105
|
128
|
|
Overall Study
COMPLETED
|
299
|
291
|
284
|
|
Overall Study
NOT COMPLETED
|
88
|
98
|
104
|
Reasons for withdrawal
| Measure |
LY2127399 Every 2 Weeks
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
22
|
27
|
26
|
|
Overall Study
Death
|
3
|
2
|
2
|
|
Overall Study
Entry Criteria Not Met
|
11
|
11
|
10
|
|
Overall Study
Lack of Efficacy
|
15
|
12
|
17
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
6
|
|
Overall Study
Parent/Caregiver Decision
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
16
|
19
|
22
|
|
Overall Study
Physician Decision
|
3
|
3
|
4
|
|
Overall Study
Protocol Violation
|
1
|
3
|
3
|
|
Overall Study
Sponsor Decision
|
6
|
5
|
4
|
|
Overall Study
Excluded Site
|
5
|
11
|
8
|
|
Overall Study
Randomized, No Study Drug Received
|
1
|
0
|
1
|
Baseline Characteristics
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
LY2127399 Every 2 Weeks
n=381 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=378 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=379 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
Total
n=1138 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 12.51 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 11.21 • n=7 Participants
|
39.1 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 11.82 • n=4 Participants
|
|
Sex: Female, Male
Female
|
354 Participants
n=5 Participants
|
352 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
1066 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
119 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
357 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
233 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
687 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
65 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
187 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
68 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
195 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
204 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
627 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Colombia
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
Singapore
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
128 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
377 Participants
n=4 Participants
|
|
Region of Enrollment
Philippines
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Region of Enrollment
Egypt
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Region of Enrollment
Thailand
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Region of Enrollment
Belarus
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
Macedonia
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Region of Enrollment
Guatemala
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Region of Enrollment
Chile
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
Peru
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Region of Enrollment
Croatia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Anti-dsDNA Antibody Level
|
107.2 International Units/Milliliter (IU/mL)
STANDARD_DEVIATION 113.50 • n=5 Participants
|
110.4 International Units/Milliliter (IU/mL)
STANDARD_DEVIATION 111.58 • n=7 Participants
|
107.1 International Units/Milliliter (IU/mL)
STANDARD_DEVIATION 112.40 • n=5 Participants
|
108.2 International Units/Milliliter (IU/mL)
STANDARD_DEVIATION 112.41 • n=4 Participants
|
|
Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Score
|
10.2 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 3.6 • n=7 Participants
|
10.7 units on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 3.7 • n=4 Participants
|
|
Physician's Global Assessment (PGA) Score
|
46.3 millimeters (mm)
STANDARD_DEVIATION 15.7 • n=5 Participants
|
46.1 millimeters (mm)
STANDARD_DEVIATION 16.2 • n=7 Participants
|
47.1 millimeters (mm)
STANDARD_DEVIATION 16.10 • n=5 Participants
|
46.5 millimeters (mm)
STANDARD_DEVIATION 16.0 • n=4 Participants
|
|
Time of Onset of Lupus
|
7.5 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
8.1 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
6.4 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
7.3 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
|
At Least One BILAG A or Two BILAG B Disease Activity Scores
Yes
|
360 Participants
n=5 Participants
|
340 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
1047 Participants
n=4 Participants
|
|
At Least One BILAG A or Two BILAG B Disease Activity Scores
No
|
21 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Lupus Quality of Life (lupus QOL) Domain Score
Physical Health
|
59.2 units on a scale
STANDARD_DEVIATION 24.98 • n=5 Participants
|
59.1 units on a scale
STANDARD_DEVIATION 25.13 • n=7 Participants
|
56.9 units on a scale
STANDARD_DEVIATION 26.17 • n=5 Participants
|
58.4 units on a scale
STANDARD_DEVIATION 25.43 • n=4 Participants
|
|
Lupus Quality of Life (lupus QOL) Domain Score
Emotional Health
|
65.7 units on a scale
STANDARD_DEVIATION 25.19 • n=5 Participants
|
66.7 units on a scale
STANDARD_DEVIATION 23.99 • n=7 Participants
|
64.6 units on a scale
STANDARD_DEVIATION 26.22 • n=5 Participants
|
65.7 units on a scale
STANDARD_DEVIATION 25.14 • n=4 Participants
|
|
Lupus Quality of Life (lupus QOL) Domain Score
Body Image
|
61.1 units on a scale
STANDARD_DEVIATION 28.99 • n=5 Participants
|
63.2 units on a scale
STANDARD_DEVIATION 27.67 • n=7 Participants
|
61.9 units on a scale
STANDARD_DEVIATION 29.20 • n=5 Participants
|
62.1 units on a scale
STANDARD_DEVIATION 28.61 • n=4 Participants
|
|
Lupus Quality of Life (lupus QOL) Domain Score
Pain
|
56.1 units on a scale
STANDARD_DEVIATION 28.40 • n=5 Participants
|
56.9 units on a scale
STANDARD_DEVIATION 26.75 • n=7 Participants
|
53.6 units on a scale
STANDARD_DEVIATION 28.62 • n=5 Participants
|
55.5 units on a scale
STANDARD_DEVIATION 27.95 • n=4 Participants
|
|
Lupus Quality of Life (lupus QOL) Domain Score
Planning
|
61.2 units on a scale
STANDARD_DEVIATION 30.37 • n=5 Participants
|
62.1 units on a scale
STANDARD_DEVIATION 28.69 • n=7 Participants
|
59.0 units on a scale
STANDARD_DEVIATION 30.92 • n=5 Participants
|
60.8 units on a scale
STANDARD_DEVIATION 30.01 • n=4 Participants
|
|
Lupus Quality of Life (lupus QOL) Domain Score
Fatigue
|
56.0 units on a scale
STANDARD_DEVIATION 26.39 • n=5 Participants
|
54.4 units on a scale
STANDARD_DEVIATION 25.54 • n=7 Participants
|
53.4 units on a scale
STANDARD_DEVIATION 27.14 • n=5 Participants
|
54.6 units on a scale
STANDARD_DEVIATION 26.36 • n=4 Participants
|
|
Lupus Quality of Life (lupus QOL) Domain Score
Intimate Relationships
|
56.2 units on a scale
STANDARD_DEVIATION 33.92 • n=5 Participants
|
63.3 units on a scale
STANDARD_DEVIATION 31.53 • n=7 Participants
|
56.8 units on a scale
STANDARD_DEVIATION 34.21 • n=5 Participants
|
58.8 units on a scale
STANDARD_DEVIATION 33.36 • n=4 Participants
|
|
Lupus Quality of Life (lupus QOL) Domain Score
Burden to Others
|
52.8 units on a scale
STANDARD_DEVIATION 30.70 • n=5 Participants
|
51.9 units on a scale
STANDARD_DEVIATION 30.31 • n=7 Participants
|
49.3 units on a scale
STANDARD_DEVIATION 32.39 • n=5 Participants
|
51.3 units on a scale
STANDARD_DEVIATION 31.15 • n=4 Participants
|
|
Brief Fatigue Inventory (BFI) Score (Worst Level of Fatigue in the Last 24 Hours)
|
5.8 units on a scale
STANDARD_DEVIATION 2.57 • n=5 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 2.81 • n=7 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 2.81 • n=5 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 2.73 • n=4 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Intent to Treat population (ITT) all randomized participants who received at least 1 dose of study drug and evaluable SLE scores, excluding two sites' participants due to good clinical practice (GCP) issues.
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.
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=381 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=378 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=379 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Percentage of Participants Achieving an SLE Responder Index Response at Week 52
|
31.8 percentage of participants
|
35.2 percentage of participants
|
29.3 percentage of participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All randomized participants who received at least 1 dose of study drug, a baseline use of prednisone or equivalent \>7.5 mg/day, excluding two sites' participants due to good clinical practice (GCP) issues.
A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit. Only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included.
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=197 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=200 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=196 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
|
15.5 percentage of partipants
|
17.0 percentage of partipants
|
16.4 percentage of partipants
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues and a non-missing result at Week 52.
Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=381 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=378 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=377 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level
|
107.2 international units
Standard Deviation 113.50
|
110.4 international units
Standard Deviation 111.58
|
107.1 international units
Standard Deviation 112.40
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
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.
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=377 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=374 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=376 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score
|
-4.7 units on a scale
Standard Deviation 4.35
|
-4.9 units on a scale
Standard Deviation 4.32
|
-4.6 units on a scale
Standard Deviation 4.54
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: Zero participants analyzed. Time to first severe SLE flare data was not collected for analysis.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeksPopulation: All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues
Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100 millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening is defined as increase of ≥0.3 points.
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=381 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=378 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=379 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
|
64.3 percentage of participants
|
61.4 percentage of participants
|
58.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
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).
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=362 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=363 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=361 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores
|
-0.9 units on a scale
Standard Deviation 3.09
|
-0.9 units on a scale
Standard Deviation 3.14
|
-0.6 units on a scale
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and a non-missing result.
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.
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=381 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=378 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=361 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Fatigue
|
70.4 units on a scale
Standard Deviation 25.51
|
68.8 units on a scale
Standard Deviation 26.34
|
64.5 units on a scale
Standard Deviation 24.94
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Physical Health
|
73.7 units on a scale
Standard Deviation 26.05
|
72.8 units on a scale
Standard Deviation 24.53
|
72.8 units on a scale
Standard Deviation 23.70
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Emotional Health
|
75.2 units on a scale
Standard Deviation 25.50
|
72.4 units on a scale
Standard Deviation 24.08
|
73.1 units on a scale
Standard Deviation 25.54
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Body Language
|
75.1 units on a scale
Standard Deviation 26.21
|
75.0 units on a scale
Standard Deviation 24.82
|
71.9 units on a scale
Standard Deviation 28.90
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Pain
|
74.0 units on a scale
Standard Deviation 27.42
|
74.1 units on a scale
Standard Deviation 24.94
|
73.2 units on a scale
Standard Deviation 27.30
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Planning
|
77.3 units on a scale
Standard Deviation 26.53
|
75.0 units on a scale
Standard Deviation 29.07
|
74.5 units on a scale
Standard Deviation 28.93
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Intimate Relationships
|
77.4 units on a scale
Standard Deviation 29.01
|
68.8 units on a scale
Standard Deviation 34.06
|
68.7 units on a scale
Standard Deviation 30.08
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Burden to Others
|
68.7 units on a scale
Standard Deviation 30.43
|
63.5 units on a scale
Standard Deviation 30.34
|
63.7 units on a scale
Standard Deviation 30.21
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: Zero participants analyzed. Time first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares data was not collected for analysis.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores range from 0, being worst possible to 100 being very active or best possible.
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=375 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=374 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=375 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in PGA
|
-20.8 millimeters
Standard Deviation 21.97
|
-20.8 millimeters
Standard Deviation 22.33
|
-20.2 millimeters
Standard Deviation 22.42
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.
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.
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=381 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=378 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=379 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks
|
6.7 percentage of participants
|
9.1 percentage of participants
|
8.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
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.
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=381 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=378 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=376 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score
|
-4.6 units on a scale
Standard Deviation 4.19
|
-4.7 units on a scale
Standard Deviation 4.11
|
-4.8 units on a scale
Standard Deviation 4.47
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.
Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score) SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Patients who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=381 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=378 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=379 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
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
Non-Responder
|
68.2 percentage of participants
|
64.8 percentage of participants
|
70.4 percentage of participants
|
|
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
Responder
|
31.8 percentage of participants
|
35.2 percentage of participants
|
29.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.
The BILAG2004 index is a validated global disease activity index designed on the basis of the physician's ITT, focusing on changes in disease manifestations (new, improved, worsening, etc) occurring in the last 4 weeks compared with the previous 4 weeks. The instrument assesses 97 clinical signs, symptoms, and laboratory parameters across 9 organ system domains: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, opthalmic, renal and hematology.
Outcome measures
| Measure |
LY2127399 Every 2 Weeks
n=381 Participants
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=378 Participants
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=379 Participants
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
|---|---|---|---|
|
Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline
|
247 Participants
|
234 Participants
|
219 Participants
|
Adverse Events
LY2127399 Every 2 Weeks
Serious events: 42 serious events
Other events: 250 other events
Deaths: 0 deaths
LY2127399 Every 4 Wks
Serious events: 56 serious events
Other events: 243 other events
Deaths: 0 deaths
Placebo
Serious events: 50 serious events
Other events: 246 other events
Deaths: 0 deaths
LY2127399 Every 2 Weeks, Follow Up
Serious events: 14 serious events
Other events: 13 other events
Deaths: 0 deaths
LY2127399 Every 4 Wks, Follow Up
Serious events: 16 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo, Follow Up
Serious events: 23 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2127399 Every 2 Weeks
n=386 participants at risk
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=389 participants at risk
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=387 participants at risk
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
LY2127399 Every 2 Weeks, Follow Up
n=103 participants at risk
24-48 weeks post last dose
|
LY2127399 Every 4 Wks, Follow Up
n=105 participants at risk
24-48 weeks post last dose
|
Placebo, Follow Up
n=128 participants at risk
24-48 weeks post last dose
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.51%
2/389 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.52%
2/386 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.52%
2/387 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Lupus endocarditis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocarditis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.52%
2/386 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vasculitis gastrointestinal
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.52%
2/387 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Type III immune complex mediated reaction
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.52%
2/386 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Arthritis bacterial
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.52%
2/387 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.51%
2/389 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Haematoma infection
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Mycobacterial infection
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Osteomyelitis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pancreas infection
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Parotitis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.3%
5/386 • Number of events 5
All participants who received at least 1 dose of study drug.
|
2.1%
8/389 • Number of events 9
All participants who received at least 1 dose of study drug.
|
1.0%
4/387 • Number of events 4
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
1.9%
2/105 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis acute
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.26%
1/386 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tracheobronchitis
|
0.52%
2/386 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.78%
3/386 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
7/386 • Number of events 7
All participants who received at least 1 dose of study drug.
|
0.51%
2/389 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.77%
3/389 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.51%
2/389 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.51%
2/389 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
SLE arthritis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.52%
2/386 • Number of events 2
All participants who received at least 1 dose of study drug.
|
1.0%
4/389 • Number of events 4
All participants who received at least 1 dose of study drug.
|
1.3%
5/387 • Number of events 5
All participants who received at least 1 dose of study drug.
|
3.9%
4/103 • Number of events 4
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
1.6%
2/128 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brenner tumour
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Central nervous system inflammation
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropsychiatric lupus
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Vasculitis cerebral
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Affect lability
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Major depression
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Glomerulonephritis proliferative
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Lupus cystitis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.52%
2/386 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
1.0%
4/387 • Number of events 4
All participants who received at least 1 dose of study drug.
|
2.9%
3/103 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
5.5%
7/128 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Mesangioproliferative glomerulonephritis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.95%
1/105 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.52%
2/387 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.26%
1/386 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.52%
2/387 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Female sterilisation
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.52%
2/386 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
LY2127399 Every 2 Weeks
n=386 participants at risk
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Wks
n=389 participants at risk
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=387 participants at risk
Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose
|
LY2127399 Every 2 Weeks, Follow Up
n=103 participants at risk
24-48 weeks post last dose
|
LY2127399 Every 4 Wks, Follow Up
n=105 participants at risk
24-48 weeks post last dose
|
Placebo, Follow Up
n=128 participants at risk
24-48 weeks post last dose
|
|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
2.1%
8/386 • Number of events 8
All participants who received at least 1 dose of study drug.
|
0.77%
3/389 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.26%
1/387 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
8/386 • Number of events 8
All participants who received at least 1 dose of study drug.
|
3.1%
12/389 • Number of events 14
All participants who received at least 1 dose of study drug.
|
3.1%
12/387 • Number of events 12
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
10/386 • Number of events 11
All participants who received at least 1 dose of study drug.
|
2.8%
11/389 • Number of events 12
All participants who received at least 1 dose of study drug.
|
2.8%
11/387 • Number of events 11
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
11/386 • Number of events 11
All participants who received at least 1 dose of study drug.
|
1.8%
7/389 • Number of events 7
All participants who received at least 1 dose of study drug.
|
2.8%
11/387 • Number of events 11
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
22/386 • Number of events 26
All participants who received at least 1 dose of study drug.
|
7.5%
29/389 • Number of events 33
All participants who received at least 1 dose of study drug.
|
5.9%
23/387 • Number of events 30
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
8/386 • Number of events 9
All participants who received at least 1 dose of study drug.
|
2.1%
8/389 • Number of events 8
All participants who received at least 1 dose of study drug.
|
2.6%
10/387 • Number of events 17
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
12/386 • Number of events 13
All participants who received at least 1 dose of study drug.
|
1.5%
6/389 • Number of events 6
All participants who received at least 1 dose of study drug.
|
1.8%
7/387 • Number of events 7
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.8%
11/386 • Number of events 11
All participants who received at least 1 dose of study drug.
|
1.8%
7/389 • Number of events 7
All participants who received at least 1 dose of study drug.
|
1.8%
7/387 • Number of events 9
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
17/386 • Number of events 19
All participants who received at least 1 dose of study drug.
|
8.0%
31/389 • Number of events 42
All participants who received at least 1 dose of study drug.
|
5.4%
21/387 • Number of events 24
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
16/386 • Number of events 19
All participants who received at least 1 dose of study drug.
|
3.6%
14/389 • Number of events 17
All participants who received at least 1 dose of study drug.
|
2.8%
11/387 • Number of events 12
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
2.6%
10/386 • Number of events 12
All participants who received at least 1 dose of study drug.
|
3.9%
15/389 • Number of events 16
All participants who received at least 1 dose of study drug.
|
2.6%
10/387 • Number of events 11
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site reaction
|
2.8%
11/386 • Number of events 17
All participants who received at least 1 dose of study drug.
|
1.8%
7/389 • Number of events 10
All participants who received at least 1 dose of study drug.
|
1.6%
6/387 • Number of events 8
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
2.8%
11/386 • Number of events 11
All participants who received at least 1 dose of study drug.
|
2.1%
8/389 • Number of events 9
All participants who received at least 1 dose of study drug.
|
2.6%
10/387 • Number of events 11
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
2.1%
8/386 • Number of events 9
All participants who received at least 1 dose of study drug.
|
2.6%
10/389 • Number of events 14
All participants who received at least 1 dose of study drug.
|
2.1%
8/387 • Number of events 16
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
3.9%
15/386 • Number of events 18
All participants who received at least 1 dose of study drug.
|
4.9%
19/389 • Number of events 19
All participants who received at least 1 dose of study drug.
|
4.4%
17/387 • Number of events 19
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
2.3%
9/386 • Number of events 11
All participants who received at least 1 dose of study drug.
|
2.1%
8/389 • Number of events 10
All participants who received at least 1 dose of study drug.
|
1.6%
6/387 • Number of events 6
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
1.0%
4/386 • Number of events 5
All participants who received at least 1 dose of study drug.
|
2.1%
8/389 • Number of events 8
All participants who received at least 1 dose of study drug.
|
2.3%
9/387 • Number of events 10
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
2.6%
10/386 • Number of events 11
All participants who received at least 1 dose of study drug.
|
2.3%
9/389 • Number of events 10
All participants who received at least 1 dose of study drug.
|
2.8%
11/387 • Number of events 12
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
3.4%
13/386 • Number of events 13
All participants who received at least 1 dose of study drug.
|
1.0%
4/389 • Number of events 5
All participants who received at least 1 dose of study drug.
|
2.3%
9/387 • Number of events 9
All participants who received at least 1 dose of study drug.
|
0.97%
1/103 • Number of events 1
All participants who received at least 1 dose of study drug.
|
1.9%
2/105 • Number of events 2
All participants who received at least 1 dose of study drug.
|
2.3%
3/128 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
2.3%
9/386 • Number of events 10
All participants who received at least 1 dose of study drug.
|
1.3%
5/389 • Number of events 5
All participants who received at least 1 dose of study drug.
|
1.6%
6/387 • Number of events 6
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
29/386 • Number of events 46
All participants who received at least 1 dose of study drug.
|
8.5%
33/389 • Number of events 35
All participants who received at least 1 dose of study drug.
|
9.6%
37/387 • Number of events 48
All participants who received at least 1 dose of study drug.
|
2.9%
3/103 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
1.6%
6/386 • Number of events 7
All participants who received at least 1 dose of study drug.
|
0.77%
3/389 • Number of events 3
All participants who received at least 1 dose of study drug.
|
2.1%
8/387 • Number of events 9
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
3.4%
13/386 • Number of events 17
All participants who received at least 1 dose of study drug.
|
4.6%
18/389 • Number of events 19
All participants who received at least 1 dose of study drug.
|
3.6%
14/387 • Number of events 18
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
4.1%
16/386 • Number of events 22
All participants who received at least 1 dose of study drug.
|
3.9%
15/389 • Number of events 16
All participants who received at least 1 dose of study drug.
|
2.8%
11/387 • Number of events 11
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.2%
55/386 • Number of events 86
All participants who received at least 1 dose of study drug.
|
10.5%
41/389 • Number of events 55
All participants who received at least 1 dose of study drug.
|
13.2%
51/387 • Number of events 72
All participants who received at least 1 dose of study drug.
|
2.9%
3/103 • Number of events 3
All participants who received at least 1 dose of study drug.
|
2.9%
3/105 • Number of events 3
All participants who received at least 1 dose of study drug.
|
3.1%
4/128 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
17.6%
68/386 • Number of events 100
All participants who received at least 1 dose of study drug.
|
13.4%
52/389 • Number of events 76
All participants who received at least 1 dose of study drug.
|
13.2%
51/387 • Number of events 77
All participants who received at least 1 dose of study drug.
|
5.8%
6/103 • Number of events 6
All participants who received at least 1 dose of study drug.
|
1.9%
2/105 • Number of events 2
All participants who received at least 1 dose of study drug.
|
3.1%
4/128 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.8%
7/386 • Number of events 7
All participants who received at least 1 dose of study drug.
|
2.3%
9/389 • Number of events 12
All participants who received at least 1 dose of study drug.
|
2.1%
8/387 • Number of events 11
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.1%
8/386 • Number of events 9
All participants who received at least 1 dose of study drug.
|
1.0%
4/389 • Number of events 5
All participants who received at least 1 dose of study drug.
|
0.52%
2/387 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.3%
9/386 • Number of events 11
All participants who received at least 1 dose of study drug.
|
0.26%
1/389 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.78%
3/387 • Number of events 4
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
14/386 • Number of events 15
All participants who received at least 1 dose of study drug.
|
3.9%
15/389 • Number of events 17
All participants who received at least 1 dose of study drug.
|
2.8%
11/387 • Number of events 14
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
15/386 • Number of events 15
All participants who received at least 1 dose of study drug.
|
7.2%
28/389 • Number of events 30
All participants who received at least 1 dose of study drug.
|
4.9%
19/387 • Number of events 24
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.0%
4/386 • Number of events 5
All participants who received at least 1 dose of study drug.
|
2.1%
8/389 • Number of events 8
All participants who received at least 1 dose of study drug.
|
1.8%
7/387 • Number of events 7
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.52%
2/386 • Number of events 2
All participants who received at least 1 dose of study drug.
|
2.1%
8/389 • Number of events 8
All participants who received at least 1 dose of study drug.
|
2.1%
8/387 • Number of events 8
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.26%
1/386 • Number of events 1
All participants who received at least 1 dose of study drug.
|
1.5%
6/389 • Number of events 6
All participants who received at least 1 dose of study drug.
|
2.6%
10/387 • Number of events 12
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
9/386 • Number of events 11
All participants who received at least 1 dose of study drug.
|
1.5%
6/389 • Number of events 6
All participants who received at least 1 dose of study drug.
|
2.3%
9/387 • Number of events 9
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
7/386 • Number of events 8
All participants who received at least 1 dose of study drug.
|
1.3%
5/389 • Number of events 7
All participants who received at least 1 dose of study drug.
|
2.1%
8/387 • Number of events 9
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.6%
6/386 • Number of events 6
All participants who received at least 1 dose of study drug.
|
4.9%
19/389 • Number of events 31
All participants who received at least 1 dose of study drug.
|
3.9%
15/387 • Number of events 15
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
8.8%
34/386 • Number of events 48
All participants who received at least 1 dose of study drug.
|
9.0%
35/389 • Number of events 56
All participants who received at least 1 dose of study drug.
|
11.6%
45/387 • Number of events 54
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
2.9%
3/105 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/386
All participants who received at least 1 dose of study drug.
|
0.00%
0/389
All participants who received at least 1 dose of study drug.
|
0.00%
0/387
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
1.9%
2/105 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.78%
1/128 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
1.6%
6/386 • Number of events 7
All participants who received at least 1 dose of study drug.
|
2.1%
8/389 • Number of events 8
All participants who received at least 1 dose of study drug.
|
1.6%
6/387 • Number of events 7
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
1.8%
7/386 • Number of events 7
All participants who received at least 1 dose of study drug.
|
3.1%
12/389 • Number of events 13
All participants who received at least 1 dose of study drug.
|
3.1%
12/387 • Number of events 12
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
5.7%
22/386 • Number of events 22
All participants who received at least 1 dose of study drug.
|
4.4%
17/389 • Number of events 17
All participants who received at least 1 dose of study drug.
|
4.1%
16/387 • Number of events 17
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
10/386 • Number of events 11
All participants who received at least 1 dose of study drug.
|
3.1%
12/389 • Number of events 13
All participants who received at least 1 dose of study drug.
|
4.7%
18/387 • Number of events 18
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
5/386 • Number of events 5
All participants who received at least 1 dose of study drug.
|
1.5%
6/389 • Number of events 6
All participants who received at least 1 dose of study drug.
|
2.6%
10/387 • Number of events 11
All participants who received at least 1 dose of study drug.
|
0.00%
0/103
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
3.6%
14/386 • Number of events 14
All participants who received at least 1 dose of study drug.
|
3.3%
13/389 • Number of events 13
All participants who received at least 1 dose of study drug.
|
5.2%
20/387 • Number of events 21
All participants who received at least 1 dose of study drug.
|
3.9%
4/103 • Number of events 4
All participants who received at least 1 dose of study drug.
|
0.00%
0/105
All participants who received at least 1 dose of study drug.
|
0.00%
0/128
All participants who received at least 1 dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60