Trial Outcomes & Findings for A Study of LY2127399 in Participants With Systemic Lupus Erythematosus (NCT NCT01205438)
NCT ID: NCT01205438
Last Updated: 2018-07-17
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
1124 participants
Primary outcome timeframe
52 weeks
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
LY2127399 Every 2 Weeks
120mg LY2127399 administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Weeks
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
120mg LY2127399 administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
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
|
372
|
376
|
376
|
|
Overall Study
Received At Least One Dose of Study Drug
|
371
|
374
|
376
|
|
Overall Study
Participated in Follow Up
|
72
|
78
|
66
|
|
Overall Study
COMPLETED
|
295
|
289
|
288
|
|
Overall Study
NOT COMPLETED
|
77
|
87
|
88
|
Reasons for withdrawal
| Measure |
LY2127399 Every 2 Weeks
120mg LY2127399 administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Weeks
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
120mg LY2127399 administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
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
|
19
|
17
|
24
|
|
Overall Study
Death
|
1
|
1
|
3
|
|
Overall Study
Entry Criteria Not Met
|
16
|
15
|
13
|
|
Overall Study
Lack of Efficacy
|
14
|
11
|
14
|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
8
|
|
Overall Study
Withdrawal by Subject
|
19
|
25
|
19
|
|
Overall Study
Physician Decision
|
0
|
3
|
2
|
|
Overall Study
Protocol Violation
|
2
|
7
|
4
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
1
|
Baseline Characteristics
All enrolled participants with LupusQOL baseline data.
Baseline characteristics by cohort
| Measure |
LY2127399 Every 2 Weeks
n=372 Participants
120mg LY2127399 administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
|
LY2127399 Every 4 Weeks
n=376 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
120mg LY2127399 administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
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.
|
Total
n=1124 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 12.41 • n=372 Participants
|
41.2 years
STANDARD_DEVIATION 12.73 • n=376 Participants
|
41.9 years
STANDARD_DEVIATION 12.08 • n=376 Participants
|
41.8 years
STANDARD_DEVIATION 12.40 • n=1124 Participants
|
|
Sex: Female, Male
Female
|
342 Participants
n=372 Participants
|
346 Participants
n=376 Participants
|
349 Participants
n=376 Participants
|
1037 Participants
n=1124 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=372 Participants
|
30 Participants
n=376 Participants
|
27 Participants
n=376 Participants
|
87 Participants
n=1124 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
110 Participants
n=372 Participants
|
92 Participants
n=376 Participants
|
99 Participants
n=376 Participants
|
301 Participants
n=1124 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
229 Participants
n=372 Participants
|
233 Participants
n=376 Participants
|
235 Participants
n=376 Participants
|
697 Participants
n=1124 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=372 Participants
|
51 Participants
n=376 Participants
|
42 Participants
n=376 Participants
|
126 Participants
n=1124 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
31 Participants
n=372 Participants
|
33 Participants
n=376 Participants
|
30 Participants
n=376 Participants
|
94 Participants
n=1124 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=372 Participants
|
34 Participants
n=376 Participants
|
40 Participants
n=376 Participants
|
112 Participants
n=1124 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=372 Participants
|
2 Participants
n=376 Participants
|
0 Participants
n=376 Participants
|
3 Participants
n=1124 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=372 Participants
|
46 Participants
n=376 Participants
|
51 Participants
n=376 Participants
|
140 Participants
n=1124 Participants
|
|
Race (NIH/OMB)
White
|
245 Participants
n=372 Participants
|
247 Participants
n=376 Participants
|
249 Participants
n=376 Participants
|
741 Participants
n=1124 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=372 Participants
|
14 Participants
n=376 Participants
|
6 Participants
n=376 Participants
|
34 Participants
n=1124 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=372 Participants
|
0 Participants
n=376 Participants
|
0 Participants
n=376 Participants
|
0 Participants
n=1124 Participants
|
|
Region of Enrollment
Ecuador
|
20 Participants
n=372 Participants
|
17 Participants
n=376 Participants
|
12 Participants
n=376 Participants
|
49 Participants
n=1124 Participants
|
|
Region of Enrollment
Russia
|
12 Participants
n=372 Participants
|
19 Participants
n=376 Participants
|
12 Participants
n=376 Participants
|
43 Participants
n=1124 Participants
|
|
Region of Enrollment
Romania
|
9 Participants
n=372 Participants
|
8 Participants
n=376 Participants
|
13 Participants
n=376 Participants
|
30 Participants
n=1124 Participants
|
|
Region of Enrollment
Hungary
|
18 Participants
n=372 Participants
|
17 Participants
n=376 Participants
|
18 Participants
n=376 Participants
|
53 Participants
n=1124 Participants
|
|
Region of Enrollment
United States
|
143 Participants
n=372 Participants
|
137 Participants
n=376 Participants
|
148 Participants
n=376 Participants
|
428 Participants
n=1124 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=372 Participants
|
3 Participants
n=376 Participants
|
3 Participants
n=376 Participants
|
9 Participants
n=1124 Participants
|
|
Region of Enrollment
Malaysia
|
2 Participants
n=372 Participants
|
1 Participants
n=376 Participants
|
4 Participants
n=376 Participants
|
7 Participants
n=1124 Participants
|
|
Region of Enrollment
India
|
11 Participants
n=372 Participants
|
13 Participants
n=376 Participants
|
16 Participants
n=376 Participants
|
40 Participants
n=1124 Participants
|
|
Region of Enrollment
Spain
|
9 Participants
n=372 Participants
|
12 Participants
n=376 Participants
|
9 Participants
n=376 Participants
|
30 Participants
n=1124 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=372 Participants
|
4 Participants
n=376 Participants
|
1 Participants
n=376 Participants
|
8 Participants
n=1124 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=372 Participants
|
3 Participants
n=376 Participants
|
2 Participants
n=376 Participants
|
8 Participants
n=1124 Participants
|
|
Region of Enrollment
Latvia
|
3 Participants
n=372 Participants
|
4 Participants
n=376 Participants
|
2 Participants
n=376 Participants
|
9 Participants
n=1124 Participants
|
|
Region of Enrollment
Taiwan
|
20 Participants
n=372 Participants
|
14 Participants
n=376 Participants
|
16 Participants
n=376 Participants
|
50 Participants
n=1124 Participants
|
|
Region of Enrollment
Brazil
|
23 Participants
n=372 Participants
|
25 Participants
n=376 Participants
|
22 Participants
n=376 Participants
|
70 Participants
n=1124 Participants
|
|
Region of Enrollment
Mexico
|
19 Participants
n=372 Participants
|
22 Participants
n=376 Participants
|
23 Participants
n=376 Participants
|
64 Participants
n=1124 Participants
|
|
Region of Enrollment
South Africa
|
14 Participants
n=372 Participants
|
17 Participants
n=376 Participants
|
7 Participants
n=376 Participants
|
38 Participants
n=1124 Participants
|
|
Region of Enrollment
Israel
|
9 Participants
n=372 Participants
|
7 Participants
n=376 Participants
|
12 Participants
n=376 Participants
|
28 Participants
n=1124 Participants
|
|
Region of Enrollment
Serbia
|
19 Participants
n=372 Participants
|
25 Participants
n=376 Participants
|
32 Participants
n=376 Participants
|
76 Participants
n=1124 Participants
|
|
Region of Enrollment
Australia
|
9 Participants
n=372 Participants
|
7 Participants
n=376 Participants
|
3 Participants
n=376 Participants
|
19 Participants
n=1124 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=372 Participants
|
1 Participants
n=376 Participants
|
1 Participants
n=376 Participants
|
4 Participants
n=1124 Participants
|
|
Region of Enrollment
Tunisia
|
21 Participants
n=372 Participants
|
20 Participants
n=376 Participants
|
20 Participants
n=376 Participants
|
61 Participants
n=1124 Participants
|
|
Anti-dsDNA Antibody Level
|
116.8 International Unit / Milliliter (IU/mL)
STANDARD_DEVIATION 118.17 • n=372 Participants
|
110.6 International Unit / Milliliter (IU/mL)
STANDARD_DEVIATION 113.51 • n=376 Participants
|
112.0 International Unit / Milliliter (IU/mL)
STANDARD_DEVIATION 116.60 • n=376 Participants
|
113.1 International Unit / Milliliter (IU/mL)
STANDARD_DEVIATION 116.03 • n=1124 Participants
|
|
Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Score
|
10.4 units on a scale
STANDARD_DEVIATION 4.07 • n=372 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 4.17 • n=376 Participants
|
9.8 units on a scale
STANDARD_DEVIATION 3.28 • n=376 Participants
|
10.2 units on a scale
STANDARD_DEVIATION 3.86 • n=1124 Participants
|
|
Physician's Global Assessment (PGA) Score
|
47.2 units on a scale
STANDARD_DEVIATION 15.45 • n=372 Participants
|
46.8 units on a scale
STANDARD_DEVIATION 15.60 • n=376 Participants
|
44.9 units on a scale
STANDARD_DEVIATION 16.57 • n=376 Participants
|
46.3 units on a scale
STANDARD_DEVIATION 15.90 • n=1124 Participants
|
|
At Least One BILAG A or Two BILAG B Disease Activity Scores
|
230 Participants
n=372 Participants
|
218 Participants
n=376 Participants
|
209 Participants
n=376 Participants
|
657 Participants
n=1124 Participants
|
|
Time of Onset of Lupus
|
8.36 years
STANDARD_DEVIATION 8.500 • n=372 Participants
|
7.94 years
STANDARD_DEVIATION 7.615 • n=376 Participants
|
7.74 years
STANDARD_DEVIATION 7.078 • n=376 Participants
|
8.01 years
STANDARD_DEVIATION 7.748 • n=1124 Participants
|
|
Lupus Quality of Life (LupusQOL) Domain Scores
Physical Health
|
59.2 units on a scale
STANDARD_DEVIATION 24.98 • n=366 Participants • All enrolled participants with LupusQOL baseline data.
|
59.1 units on a scale
STANDARD_DEVIATION 25.13 • n=364 Participants • All enrolled participants with LupusQOL baseline data.
|
56.9 units on a scale
STANDARD_DEVIATION 26.17 • n=365 Participants • All enrolled participants with LupusQOL baseline data.
|
58.4 units on a scale
STANDARD_DEVIATION 25.43 • n=1095 Participants • All enrolled participants with LupusQOL baseline data.
|
|
Lupus Quality of Life (LupusQOL) Domain Scores
Emotional Health
|
65.7 units on a scale
STANDARD_DEVIATION 25.19 • n=366 Participants • All enrolled participants with LupusQOL baseline data.
|
66.7 units on a scale
STANDARD_DEVIATION 23.99 • n=364 Participants • All enrolled participants with LupusQOL baseline data.
|
64.6 units on a scale
STANDARD_DEVIATION 26.22 • n=365 Participants • All enrolled participants with LupusQOL baseline data.
|
65.7 units on a scale
STANDARD_DEVIATION 25.14 • n=1095 Participants • All enrolled participants with LupusQOL baseline data.
|
|
Lupus Quality of Life (LupusQOL) Domain Scores
Body Image
|
61.1 units on a scale
STANDARD_DEVIATION 28.99 • n=338 Participants • All enrolled participants with LupusQOL baseline data.
|
63.2 units on a scale
STANDARD_DEVIATION 27.67 • n=343 Participants • All enrolled participants with LupusQOL baseline data.
|
61.9 units on a scale
STANDARD_DEVIATION 29.20 • n=342 Participants • All enrolled participants with LupusQOL baseline data.
|
62.1 units on a scale
STANDARD_DEVIATION 28.61 • n=1023 Participants • All enrolled participants with LupusQOL baseline data.
|
|
Lupus Quality of Life (LupusQOL) Domain Scores
Pain
|
56.1 units on a scale
STANDARD_DEVIATION 28.40 • n=366 Participants • All enrolled participants with LupusQOL baseline data.
|
56.9 units on a scale
STANDARD_DEVIATION 26.75 • n=364 Participants • All enrolled participants with LupusQOL baseline data.
|
53.6 units on a scale
STANDARD_DEVIATION 28.62 • n=365 Participants • All enrolled participants with LupusQOL baseline data.
|
55.5 units on a scale
STANDARD_DEVIATION 27.95 • n=1095 Participants • All enrolled participants with LupusQOL baseline data.
|
|
Lupus Quality of Life (LupusQOL) Domain Scores
Planning
|
61.2 units on a scale
STANDARD_DEVIATION 30.37 • n=366 Participants • All enrolled participants with LupusQOL baseline data.
|
62.1 units on a scale
STANDARD_DEVIATION 28.69 • n=364 Participants • All enrolled participants with LupusQOL baseline data.
|
59.0 units on a scale
STANDARD_DEVIATION 30.92 • n=365 Participants • All enrolled participants with LupusQOL baseline data.
|
60.8 units on a scale
STANDARD_DEVIATION 30.01 • n=1095 Participants • All enrolled participants with LupusQOL baseline data.
|
|
Lupus Quality of Life (LupusQOL) Domain Scores
Fatigue
|
56.0 units on a scale
STANDARD_DEVIATION 26.39 • n=366 Participants • All enrolled participants with LupusQOL baseline data.
|
54.4 units on a scale
STANDARD_DEVIATION 25.54 • n=364 Participants • All enrolled participants with LupusQOL baseline data.
|
53.4 units on a scale
STANDARD_DEVIATION 27.14 • n=365 Participants • All enrolled participants with LupusQOL baseline data.
|
54.6 units on a scale
STANDARD_DEVIATION 26.36 • n=1095 Participants • All enrolled participants with LupusQOL baseline data.
|
|
Lupus Quality of Life (LupusQOL) Domain Scores
Intimate Relationships
|
56.2 units on a scale
STANDARD_DEVIATION 33.92 • n=314 Participants • All enrolled participants with LupusQOL baseline data.
|
63.3 units on a scale
STANDARD_DEVIATION 31.53 • n=316 Participants • All enrolled participants with LupusQOL baseline data.
|
56.8 units on a scale
STANDARD_DEVIATION 34.21 • n=320 Participants • All enrolled participants with LupusQOL baseline data.
|
58.8 units on a scale
STANDARD_DEVIATION 33.36 • n=950 Participants • All enrolled participants with LupusQOL baseline data.
|
|
Lupus Quality of Life (LupusQOL) Domain Scores
Burden to Others
|
52.8 units on a scale
STANDARD_DEVIATION 30.70 • n=366 Participants • All enrolled participants with LupusQOL baseline data.
|
51.9 units on a scale
STANDARD_DEVIATION 30.31 • n=364 Participants • All enrolled participants with LupusQOL baseline data.
|
49.3 units on a scale
STANDARD_DEVIATION 32.39 • n=365 Participants • All enrolled participants with LupusQOL baseline data.
|
51.3 units on a scale
STANDARD_DEVIATION 31.15 • n=1095 Participants • All enrolled participants with LupusQOL baseline data.
|
|
Brief Fatigue Inventory (BFI) Score
|
5.8 units on a scale
STANDARD_DEVIATION 2.57 • n=372 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 2.81 • n=376 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 2.81 • n=376 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 2.73 • n=1124 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.
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 |
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.
|
LY2127399 Every 2 Weeks
n=372 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=376 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving an SLE Responder Index Response at Week 52
|
27.7 percentage of participants
|
38.5 percentage of participants
|
34.8 percentage of participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention to treat (ITT), only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included.
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.
Outcome measures
| Measure |
Placebo
n=131 Participants
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
n=146 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=129 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
|
11.5 percentage of participants
|
21.2 percentage of participants
|
14.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.
Outcome measures
| Measure |
Placebo
n=372 Participants
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
n=368 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=372 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level
|
-7.0 International Units (IU)
Standard Deviation 56.53
|
-27.7 International Units (IU)
Standard Deviation 65.31
|
-26.4 International Units (IU)
Standard Deviation 64.13
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
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 |
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.
|
LY2127399 Every 2 Weeks
n=372 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=376 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score
Baseline
|
9.8 units on a scale
Standard Deviation 3.36
|
10.3 units on a scale
Standard Deviation 4.17
|
10.4 units on a scale
Standard Deviation 4.01
|
|
Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score
52 Weeks
|
-3.6 units on a scale
Standard Deviation 4.21
|
-4.9 units on a scale
Standard Deviation 4.57
|
-4.7 units on a scale
Standard Deviation 4.62
|
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: Baseline, 52 weeksPopulation: Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
PGA is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening defined as increase of ≤ 0.30 points from Baseline.
Outcome measures
| Measure |
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.
|
LY2127399 Every 2 Weeks
n=372 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=376 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)
|
-15.1 units on a scale
Standard Deviation 23.52
|
-21.2 units on a scale
Standard Deviation 21.28
|
-19.2 units on a scale
Standard Deviation 23.13
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.
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 |
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.
|
LY2127399 Every 2 Weeks
n=372 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=376 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
Physical Health
|
70.7 units on a scale
Standard Deviation 27.78
|
69.0 units on a scale
Standard Deviation 26.42
|
66.2 units on a scale
Standard Deviation 28.01
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
Emotional Health
|
74.0 units on a scale
Standard Deviation 28.85
|
72.7 units on a scale
Standard Deviation 27.03
|
72.3 units on a scale
Standard Deviation 27.72
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
Body Image
|
73.1 units on a scale
Standard Deviation 29.76
|
73.6 units on a scale
Standard Deviation 27.79
|
72.8 units on a scale
Standard Deviation 27.60
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
Pain
|
71.4 units on a scale
Standard Deviation 29.80
|
68.5 units on a scale
Standard Deviation 28.98
|
67.5 units on a scale
Standard Deviation 29.78
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
Planning
|
73.2 units on a scale
Standard Deviation 33.39
|
71.0 units on a scale
Standard Deviation 30.04
|
70.7 units on a scale
Standard Deviation 31.71
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
Fatigue
|
69.3 units on a scale
Standard Deviation 26.27
|
65.5 units on a scale
Standard Deviation 26.23
|
62.4 units on a scale
Standard Deviation 28.17
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
Intimate Relationships
|
72.4 units on a scale
Standard Deviation 31.42
|
68.4 units on a scale
Standard Deviation 33.39
|
66.1 units on a scale
Standard Deviation 33.81
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
Burden to Others
|
69.2 units on a scale
Standard Deviation 31.33
|
62.6 units on a scale
Standard Deviation 32.89
|
63.7 units on a scale
Standard Deviation 31.06
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.
Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100.No worsening defined as increase of ≤ 0.30 points from Baseline.
Outcome measures
| Measure |
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.
|
LY2127399 Every 2 Weeks
n=372 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=376 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
|
42.8 percentage of participants
|
32.8 percentage of participants
|
37.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
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 |
Placebo
n=354 Participants
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
n=358 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=352 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores
|
-0.5 units on a scale
Standard Deviation 2.95
|
-0.7 units on a scale
Standard Deviation 3.09
|
-0.5 units on a scale
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: Zero participants analyzed. Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE flare data was not collected for analysis.
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: 52 weeksPopulation: Intention to treat (ITT), only participants receiving a prednisone or equivalent dose of more than 2.5 mg/day at baseline are included.
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 |
Placebo
n=288 Participants
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
n=295 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=289 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks
|
5.9 percentage of participants
|
4.7 percentage of participants
|
6.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.
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 |
Placebo
n=372 Participants
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
n=368 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=367 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score
|
-3.7 units on a scale
Standard Deviation 4.31
|
-5.1 units on a scale
Standard Deviation 4.62
|
-4.8 units on a scale
Standard Deviation 4.69
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: Intention to treat (ITT), all randomized participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
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.
|
LY2127399 Every 2 Weeks
n=371 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=374 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline
|
160 Participants
|
134 Participants
|
144 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention to treat (ITT), all randomized participants who received at least one dose of study drug. Non-responder imputation (NRI) included.
Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score) SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.
Outcome measures
| Measure |
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.
|
LY2127399 Every 2 Weeks
n=372 Participants
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=376 Participants
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
|---|---|---|---|
|
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
|
27.7 percentage of participants
|
38.7 percentage of participants
|
34.8 percentage of participants
|
Adverse Events
LY2127399 Every 2 Weeks
Serious events: 46 serious events
Other events: 249 other events
Deaths: 0 deaths
LY2127399 Every 4 Weeks
Serious events: 59 serious events
Other events: 239 other events
Deaths: 0 deaths
Placebo
Serious events: 70 serious events
Other events: 246 other events
Deaths: 0 deaths
LY2127399 Every 2 Weeks, Follow Up
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
LY2127399 Every 4 Wks, Follow Up
Serious events: 12 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo, Follow Up
Serious events: 14 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2127399 Every 2 Weeks
n=371 participants at risk
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=374 participants at risk
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=376 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=72 participants at risk
24-48 weeks post last dose for participants receiving LY2127399 every 2 weeks during the Treatment Period.
|
LY2127399 Every 4 Wks, Follow Up
n=78 participants at risk
24-48 weeks post last dose for participants receiving LY2127399 every 4 weeks during the Treatment Period.
|
Placebo, Follow Up
n=66 participants at risk
24-48 weeks post last dose for participants receiving placebo during the Treatment Period.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Bradycardia
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.1%
4/376 • Number of events 4
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Left ventricular failure
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Pericarditis
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Endocrine disorders
Addison's disease
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Eye disorders
Accommodation disorder
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Proctitis
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.54%
2/371 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Oedema
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Serositis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Lupus hepatitis
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Atypical pneumonia
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.54%
2/371 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.54%
2/371 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Endocarditis
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.0%
2/66 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Influenza
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Lung infection
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Perinephric abscess
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
1.1%
4/371 • Number of events 4
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.9%
7/376 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Salmonella bacteraemia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Septic shock
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Viral infection
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Wound infection
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wound
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Investigations
Weight decreased
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.54%
2/371 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.81%
3/371 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.1%
4/374 • Number of events 4
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.6%
6/376 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vagina
|
0.00%
0/341
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.29%
1/344 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/349
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/67
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/74 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/63
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/341
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/344
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.57%
2/349 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Lacunar infarction
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Vasculitis cerebral
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/67
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/74
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.6%
1/63 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Borderline personality disorder
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Dysthymic disorder
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Neurosis
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Panic attack
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.54%
2/371 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.54%
2/371 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Nephropathy
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Renal failure acute
|
0.54%
2/371 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Urethral polyp
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/341
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/344
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.29%
1/349 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.29%
1/341 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/344
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/349
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/341
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/344
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.29%
1/349 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/341
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/344
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.29%
1/349 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.29%
1/341 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/344
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/349
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.29%
1/341 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/344
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/349
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Lupus pneumonitis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Shrinking lung syndrome
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Butterfly rash
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Female sterilisation
|
0.29%
1/341 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/344
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/349
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.80%
3/374 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
Other adverse events
| Measure |
LY2127399 Every 2 Weeks
n=371 participants at risk
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
|
LY2127399 Every 4 Weeks
n=374 participants at risk
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
LY2127399: 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks.
|
Placebo
n=376 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=72 participants at risk
24-48 weeks post last dose for participants receiving LY2127399 every 2 weeks during the Treatment Period.
|
LY2127399 Every 4 Wks, Follow Up
n=78 participants at risk
24-48 weeks post last dose for participants receiving LY2127399 every 4 weeks during the Treatment Period.
|
Placebo, Follow Up
n=66 participants at risk
24-48 weeks post last dose for participants receiving placebo during the Treatment Period.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
2.2%
8/371 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.1%
4/374 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.80%
3/376 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
7/371 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.1%
8/374 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.4%
9/376 • Number of events 12
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.0%
11/371 • Number of events 16
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.5%
13/374 • Number of events 13
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.1%
8/376 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
6/371 • Number of events 6
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.4%
9/374 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.9%
11/376 • Number of events 13
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
25/371 • Number of events 29
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
5.6%
21/374 • Number of events 30
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
8.5%
32/376 • Number of events 37
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
11/371 • Number of events 14
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
5/374 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.5%
13/376 • Number of events 16
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.9%
7/371 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.9%
7/374 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.1%
8/376 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
23/371 • Number of events 25
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
5.6%
21/374 • Number of events 24
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
9.3%
35/376 • Number of events 42
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.8%
3/78 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
2.4%
9/371 • Number of events 10
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.80%
3/374 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.80%
3/376 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
4.6%
17/371 • Number of events 21
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.4%
9/374 • Number of events 12
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.5%
17/376 • Number of events 20
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Asthenia
|
2.2%
8/371 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.80%
3/376 • Number of events 4
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.8%
2/72 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Fatigue
|
3.0%
11/371 • Number of events 18
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
5/374 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.2%
12/376 • Number of events 18
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Injection site erythema
|
3.5%
13/371 • Number of events 16
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.6%
6/374 • Number of events 13
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.1%
4/376 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Injection site pain
|
2.4%
9/371 • Number of events 11
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
5/374 • Number of events 14
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
5/376 • Number of events 14
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Injection site reaction
|
2.4%
9/371 • Number of events 35
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.5%
13/374 • Number of events 20
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.1%
4/376 • Number of events 4
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.0%
2/66 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
General disorders
Pyrexia
|
1.9%
7/371 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.4%
9/374 • Number of events 11
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.1%
8/376 • Number of events 10
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.5%
3/66 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
4.9%
18/371 • Number of events 22
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
6.7%
25/374 • Number of events 29
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
5.9%
22/376 • Number of events 28
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.6%
2/78 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.6%
2/78 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
1.1%
4/371 • Number of events 4
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.1%
8/374 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.6%
6/376 • Number of events 6
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
1.9%
7/371 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.2%
12/374 • Number of events 14
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.1%
4/376 • Number of events 4
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
2.7%
10/371 • Number of events 14
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.7%
10/374 • Number of events 10
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.5%
13/376 • Number of events 14
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.8%
2/72 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
1.6%
6/371 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.7%
10/374 • Number of events 10
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.6%
6/376 • Number of events 6
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Influenza
|
3.2%
12/371 • Number of events 15
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.5%
17/374 • Number of events 20
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.6%
6/376 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.0%
2/66 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.4%
9/371 • Number of events 12
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/374 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.80%
3/376 • Number of events 4
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
24/371 • Number of events 28
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.8%
18/374 • Number of events 22
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
8.5%
32/376 • Number of events 41
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
1.1%
4/371 • Number of events 5
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.7%
10/374 • Number of events 14
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
5/376 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.8%
2/72 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
3.0%
11/371 • Number of events 12
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.4%
9/374 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.8%
18/376 • Number of events 18
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
7.0%
26/371 • Number of events 26
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
7.2%
27/374 • Number of events 30
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
5.1%
19/376 • Number of events 23
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.8%
2/72 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Tooth abscess
|
0.27%
1/371 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
5/374 • Number of events 6
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.1%
8/376 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.6%
58/371 • Number of events 74
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
11.8%
44/374 • Number of events 60
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
12.0%
45/376 • Number of events 63
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.8%
2/72 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
53/371 • Number of events 80
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
16.0%
60/374 • Number of events 81
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
16.8%
63/376 • Number of events 86
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
5.6%
4/72 • Number of events 6
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.8%
3/78 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.5%
3/66 • Number of events 4
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Vaginal infection
|
2.1%
7/341 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
5/344 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.57%
2/349 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.4%
9/371 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.6%
6/376 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
11/371 • Number of events 13
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
5/374 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.4%
9/376 • Number of events 18
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
6/371 • Number of events 6
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.4%
9/376 • Number of events 10
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Investigations
Hepatic enzyme increased
|
2.2%
8/371 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/374 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.80%
3/376 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.2%
8/371 • Number of events 10
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.1%
8/374 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.27%
1/376 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
18/371 • Number of events 21
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.0%
15/374 • Number of events 16
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.0%
15/376 • Number of events 18
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.6%
2/78 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
26/371 • Number of events 27
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
5.6%
21/374 • Number of events 27
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.5%
17/376 • Number of events 20
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.1%
4/371 • Number of events 4
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.4%
9/374 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.53%
2/376 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.4%
1/72 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.6%
2/78 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.9%
18/371 • Number of events 19
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.2%
12/374 • Number of events 14
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.4%
9/376 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
7/371 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.4%
9/374 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.7%
10/376 • Number of events 10
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
8/371 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.7%
10/374 • Number of events 10
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.80%
3/376 • Number of events 5
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.0%
2/66 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
2.2%
8/371 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.9%
11/374 • Number of events 11
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.2%
12/376 • Number of events 12
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Headache
|
9.2%
34/371 • Number of events 47
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
9.9%
37/374 • Number of events 50
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
9.0%
34/376 • Number of events 52
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.8%
2/72 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
1/78 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
2.2%
8/371 • Number of events 8
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.7%
14/374 • Number of events 17
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.1%
8/376 • Number of events 9
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/371
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/374
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/376
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/67 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/74
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.2%
2/63 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
3.8%
14/371 • Number of events 15
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.9%
11/374 • Number of events 11
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.2%
12/376 • Number of events 12
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
3.8%
14/371 • Number of events 14
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.5%
17/374 • Number of events 18
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.80%
3/376 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
3.5%
13/371 • Number of events 13
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
5.6%
21/374 • Number of events 22
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.0%
15/376 • Number of events 18
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.8%
3/78 • Number of events 3
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Penis disorder
|
3.3%
1/30 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/30
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/27
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
3.3%
1/30 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/30
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/27
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
17/371 • Number of events 18
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
3.7%
14/374 • Number of events 14
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.5%
17/376 • Number of events 18
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.8%
2/72 • Number of events 2
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.5%
1/66 • Number of events 1
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
9/371 • Number of events 10
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.7%
10/374 • Number of events 12
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.3%
5/376 • Number of events 5
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
5/371 • Number of events 5
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.7%
10/374 • Number of events 11
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.9%
7/376 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
8/371 • Number of events 12
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
1.9%
7/374 • Number of events 7
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.1%
8/376 • Number of events 12
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
4.6%
17/371 • Number of events 17
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
2.1%
8/374 • Number of events 10
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
4.3%
16/376 • Number of events 16
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/72
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/78
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
0.00%
0/66
All participants who received at least 1 dose of study drug. For gender specific events, only occurring in male or female subjects, the number of subjects exposed has been adjusted accordingly.
|
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