Trial Outcomes & Findings for Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus (NCT NCT00306384)
NCT ID: NCT00306384
Last Updated: 2013-03-22
Results Overview
Safety was assessed by physical examinations, clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, and hypoglycemic events. Changes in laboratory values or ECG parameters were considered to be adverse events if they were judged to be clinically significant. A TEAE was any event that started on or after the first dose of open-label study drug and within 14 days after the last dose.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3323 participants
Primary outcome timeframe
4 years
Results posted on
2013-03-22
Participant Flow
Patients who completed 1 of the following 7 studies took part in the study at 423 investigative sites worldwide: SYR-322-PLC-010 (NCT00286455); SYR-322-SULF-007 (NCT00286468); SYR-322-MET-008 (NCT00286442); SYR-322-TZD-009 (NCT00286494); SYR-322-INS-011 (NCT00286429); 01-05-TL-322OPI-001 (NCT00328627); 01-06-TL-322OPI-002 (NCT00395512).
Patients who had previously completed 1 of 7 double-blind alogliptin studies were randomized (1:1) to either 12.5 or 25 mg once daily alogliptin. Patients who were rescued during their previous double-blind study in response to protocol-defined hyperglycemic rescue criteria were assigned to alogliptin 25 mg.
Participant milestones
| Measure |
Alogliptin 12.5 mg
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1396
|
1399
|
528
|
|
Overall Study
Safety Set
|
1395
|
1398
|
527
|
|
Overall Study
COMPLETED
|
854
|
891
|
251
|
|
Overall Study
NOT COMPLETED
|
542
|
508
|
277
|
Reasons for withdrawal
| Measure |
Alogliptin 12.5 mg
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
103
|
87
|
40
|
|
Overall Study
Major protocol deviation
|
43
|
51
|
18
|
|
Overall Study
Lost to Follow-up
|
57
|
41
|
35
|
|
Overall Study
Voluntary withdrawal
|
199
|
187
|
91
|
|
Overall Study
Study termination
|
1
|
0
|
1
|
|
Overall Study
Pregnancy
|
3
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
26
|
40
|
38
|
|
Overall Study
Investigator discretion
|
28
|
31
|
21
|
|
Overall Study
Other
|
80
|
70
|
32
|
|
Overall Study
Site closure
|
2
|
0
|
0
|
Baseline Characteristics
Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Alogliptin 12.5 mg
n=1396 Participants
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=1399 Participants
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=528 Participants
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
Total
n=3323 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
55.8 years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 10.21 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 10.11 • n=4 Participants
|
|
Age, Customized
<65 years
|
1134 participants
n=5 Participants
|
1134 participants
n=7 Participants
|
461 participants
n=5 Participants
|
2729 participants
n=4 Participants
|
|
Age, Customized
≥65 years
|
262 participants
n=5 Participants
|
265 participants
n=7 Participants
|
67 participants
n=5 Participants
|
594 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
699 Participants
n=5 Participants
|
730 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
1718 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
697 Participants
n=5 Participants
|
669 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
1605 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
120 participants
n=5 Participants
|
108 participants
n=7 Participants
|
32 participants
n=5 Participants
|
260 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
65 participants
n=5 Participants
|
88 participants
n=7 Participants
|
34 participants
n=5 Participants
|
187 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
1025 participants
n=5 Participants
|
1007 participants
n=7 Participants
|
390 participants
n=5 Participants
|
2422 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
176 participants
n=5 Participants
|
193 participants
n=7 Participants
|
69 participants
n=5 Participants
|
438 participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
31.42 kg/m^2
STANDARD_DEVIATION 5.370 • n=5 Participants
|
31.71 kg/m^2
STANDARD_DEVIATION 5.266 • n=7 Participants
|
32.20 kg/m^2
STANDARD_DEVIATION 5.704 • n=5 Participants
|
31.66 kg/m^2
STANDARD_DEVIATION 5.386 • n=4 Participants
|
|
Diabetes duration
|
6.56 years
STANDARD_DEVIATION 5.446 • n=5 Participants
|
6.92 years
STANDARD_DEVIATION 5.824 • n=7 Participants
|
8.35 years
STANDARD_DEVIATION 6.325 • n=5 Participants
|
6.99 years
STANDARD_DEVIATION 5.784 • n=4 Participants
|
|
Previous double-blind study treatment
Placebo
|
118 participants
n=5 Participants
|
110 participants
n=7 Participants
|
135 participants
n=5 Participants
|
363 participants
n=4 Participants
|
|
Previous double-blind study treatment
Alogliptin 12.5 mg
|
274 participants
n=5 Participants
|
262 participants
n=7 Participants
|
105 participants
n=5 Participants
|
641 participants
n=4 Participants
|
|
Previous double-blind study treatment
Alogliptin 25 mg
|
243 participants
n=5 Participants
|
262 participants
n=7 Participants
|
99 participants
n=5 Participants
|
604 participants
n=4 Participants
|
|
Previous double-blind study treatment
Study 01-05-TL-322OPI-001
|
546 participants
n=5 Participants
|
548 participants
n=7 Participants
|
146 participants
n=5 Participants
|
1240 participants
n=4 Participants
|
|
Previous double-blind study treatment
Study 01-06-TL-322OPI-002
|
215 participants
n=5 Participants
|
217 participants
n=7 Participants
|
43 participants
n=5 Participants
|
475 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: Safety set
Safety was assessed by physical examinations, clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, and hypoglycemic events. Changes in laboratory values or ECG parameters were considered to be adverse events if they were judged to be clinically significant. A TEAE was any event that started on or after the first dose of open-label study drug and within 14 days after the last dose.
Outcome measures
| Measure |
Alogliptin 12.5 mg
n=1394 Participants
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=1399 Participants
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=527 Participants
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Any treatment emergent adverse event (TEAE)
|
87.2 percentage of participants
|
87.1 percentage of participants
|
84.6 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Study drug-related TEAE
|
25.6 percentage of participants
|
22.7 percentage of participants
|
24.9 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE leading to discontinuation
|
7.0 percentage of participants
|
6.1 percentage of participants
|
7.6 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment emergent serious AE
|
16.7 percentage of participants
|
16.3 percentage of participants
|
15.7 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Study drug-related serious AE
|
2.6 percentage of participants
|
2.1 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-emergent deaths
|
1.4 percentage of participants
|
1.0 percentage of participants
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42 and 45.Population: Safety set where data were available.
The change from Baseline in glycosylated hemoglobin (HbA1c; the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Endpoint was defined as the last postbaseline observation collected within 7 days after the last dose of open-label study drug.
Outcome measures
| Measure |
Alogliptin 12.5 mg
n=1395 Participants
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=1398 Participants
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=527 Participants
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Baseline (n=1362, 1359, 501)
|
7.21 percent glycosylated hemoglobin
Standard Deviation 0.815
|
7.22 percent glycosylated hemoglobin
Standard Deviation 0.814
|
9.30 percent glycosylated hemoglobin
Standard Deviation 0.900
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Week 12 change from Baseline (n=1290, 1286, 463)
|
0.18 percent glycosylated hemoglobin
Standard Deviation 0.635
|
0.14 percent glycosylated hemoglobin
Standard Deviation 0.632
|
-0.52 percent glycosylated hemoglobin
Standard Deviation 1.064
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 6 change from Baseline (n= 1236, 1252, 433)
|
0.31 percent glycosylated hemoglobin
Standard Deviation 0.859
|
0.26 percent glycosylated hemoglobin
Standard Deviation 0.848
|
-0.73 percent glycosylated hemoglobin
Standard Deviation 1.285
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 9 change from Baseline (n=1217, 1231, 413)
|
0.34 percent glycosylated hemoglobin
Standard Deviation 0.969
|
0.33 percent glycosylated hemoglobin
Standard Deviation 0.894
|
-0.78 percent glycosylated hemoglobin
Standard Deviation 1.282
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 12 change from Baseline (1175, 1182, 388)
|
0.41 percent glycosylated hemoglobin
Standard Deviation 1.010
|
0.41 percent glycosylated hemoglobin
Standard Deviation 0.952
|
-0.78 percent glycosylated hemoglobin
Standard Deviation 1.309
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 15 change from Baseline (n=1119, 1133, 374)
|
0.47 percent glycosylated hemoglobin
Standard Deviation 0.990
|
0.48 percent glycosylated hemoglobin
Standard Deviation 1.068
|
-0.75 percent glycosylated hemoglobin
Standard Deviation 1.332
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 18 change from Baseline (n=1111, 1095, 350)
|
0.50 percent glycosylated hemoglobin
Standard Deviation 1.082
|
0.50 percent glycosylated hemoglobin
Standard Deviation 1.047
|
-0.70 percent glycosylated hemoglobin
Standard Deviation 1.320
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 21 change from Baseline (n=1061, 1071, 338)
|
0.52 percent glycosylated hemoglobin
Standard Deviation 1.096
|
0.51 percent glycosylated hemoglobin
Standard Deviation 1.070
|
-0.75 percent glycosylated hemoglobin
Standard Deviation 1.389
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 24 change from Baseline (n=1027, 1039, 320)
|
0.53 percent glycosylated hemoglobin
Standard Deviation 1.111
|
0.58 percent glycosylated hemoglobin
Standard Deviation 1.107
|
-0.69 percent glycosylated hemoglobin
Standard Deviation 1.417
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 27 change from Baseline (n=991, 1002, 300)
|
0.58 percent glycosylated hemoglobin
Standard Deviation 1.124
|
0.58 percent glycosylated hemoglobin
Standard Deviation 1.159
|
-0.71 percent glycosylated hemoglobin
Standard Deviation 1.349
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 30 change from Baseline (n=944, 955, 281)
|
0.57 percent glycosylated hemoglobin
Standard Deviation 1.127
|
0.57 percent glycosylated hemoglobin
Standard Deviation 1.167
|
-0.78 percent glycosylated hemoglobin
Standard Deviation 1.361
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 33 change from Baseline (n=923, 941, 276)
|
0.55 percent glycosylated hemoglobin
Standard Deviation 1.181
|
0.57 percent glycosylated hemoglobin
Standard Deviation 1.196
|
-0.73 percent glycosylated hemoglobin
Standard Deviation 1.418
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 36 change from Baseline (n=882, 931, 274)
|
0.54 percent glycosylated hemoglobin
Standard Deviation 1.215
|
0.55 percent glycosylated hemoglobin
Standard Deviation 1.141
|
-0.80 percent glycosylated hemoglobin
Standard Deviation 1.411
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 39 change from Baseline (n=886, 913, 259)
|
0.56 percent glycosylated hemoglobin
Standard Deviation 1.223
|
0.56 percent glycosylated hemoglobin
Standard Deviation 1.216
|
-0.73 percent glycosylated hemoglobin
Standard Deviation 1.431
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 42 change from Baseline (n=854, 891, 252)
|
0.59 percent glycosylated hemoglobin
Standard Deviation 1.225
|
0.54 percent glycosylated hemoglobin
Standard Deviation 1.221
|
-0.78 percent glycosylated hemoglobin
Standard Deviation 1.492
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Month 45 change from Baseline (n=866, 902, 253)
|
0.61 percent glycosylated hemoglobin
Standard Deviation 1.250
|
0.56 percent glycosylated hemoglobin
Standard Deviation 1.242
|
-0.70 percent glycosylated hemoglobin
Standard Deviation 1.398
|
|
Change From Baseline Over Time in Glycosylated Hemoglobin
Endpoint change from Baseline (n=1362, 1359, 501)
|
1.63 percent glycosylated hemoglobin
Standard Deviation 1.310
|
0.61 percent glycosylated hemoglobin
Standard Deviation 1.261
|
-0.42 percent glycosylated hemoglobin
Standard Deviation 1.448
|
SECONDARY outcome
Timeframe: Baseline and Year 4Population: Safety set where data were available.
The change from Baseline in fasting plasma glucose (FPG) at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.
Outcome measures
| Measure |
Alogliptin 12.5 mg
n=1388 Participants
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=1386 Participants
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=517 Participants
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose
Baseline
|
144.4 mg/dL
Standard Deviation 41.64
|
142.6 mg/dL
Standard Deviation 39.41
|
215.3 mg/dL
Standard Deviation 60.25
|
|
Change From Baseline in Fasting Plasma Glucose
Change from Baseline
|
14.8 mg/dL
Standard Deviation 56.25
|
14.9 mg/dL
Standard Deviation 53.46
|
-26.4 mg/dL
Standard Deviation 84.51
|
SECONDARY outcome
Timeframe: Randomization up to 4 years.Population: Safety set where data were available.
Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (≥11.10 mmol/L). The Month 42 to Month 45 interval includes all marked hyperglycemic episodes occurring on or after Day 1247 (a 203-day visit window).
Outcome measures
| Measure |
Alogliptin 12.5 mg
n=1395 Participants
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=1398 Participants
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=527 Participants
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Percentage of Participants With Marked Hyperglycemia
Month 36 to <Month 39 (n=920, 949, 281)
|
13.2 percentage of participants
|
12.5 percentage of participants
|
21.0 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Day 1 to <Week 2 (n=1299, 1290, 481)
|
9.1 percentage of participants
|
8.0 percentage of participants
|
55.5 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Week 2 to <Week 4 (n=1286, 1306, 481)
|
11.5 percentage of participants
|
10.2 percentage of participants
|
45.9 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Week 4 to <Week 8 (n=1303, 1331, 490)
|
9.2 percentage of participants
|
11.0 percentage of participants
|
46.1 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Week 8 to <Week 12 (n=1331, 1347, 495)
|
11.5 percentage of participants
|
10.8 percentage of participants
|
41.0 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Week 12 to <Month 6 (n=1329, 1338, 480)
|
12.0 percentage of participants
|
11.6 percentage of participants
|
39.4 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 6 to <Month 9 (n=1286, 1289, 448)
|
12.8 percentage of participants
|
10.7 percentage of participants
|
36.8 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 9 to <Month 12 (n=1252, 1260, 425)
|
11.4 percentage of participants
|
12.9 percentage of participants
|
32.5 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 12 to <Month 15 (n=1210, 1217, 409)
|
13.1 percentage of participants
|
13.0 percentage of participants
|
29.3 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 15 to <Month 18 (n=1157, 1166, 389)
|
12.7 percentage of participants
|
13.8 percentage of participants
|
27.8 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 18 to <Month 21 (n=1128, 1128, 365)
|
11.7 percentage of participants
|
11.6 percentage of participants
|
26.8 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 21 to <Month 24 (n=1094,1099, 357)
|
11.2 percentage of participants
|
11.5 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 24 to <Month 27 (n=1046, 1066, 334)
|
11.6 percentage of participants
|
12.3 percentage of participants
|
24.9 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 27 to <Month 30 (n=1010, 1028, 316)
|
12.6 percentage of participants
|
11.8 percentage of participants
|
24.7 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 30 to <Month 33 (n=981, 988, 299)
|
11.6 percentage of participants
|
11.7 percentage of participants
|
19.7 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 33 to <Month 36 (n=945, 959, 289)
|
11.5 percentage of participants
|
12.3 percentage of participants
|
23.5 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 39 to <Month 42 (n=899, 934, 267)
|
13.7 percentage of participants
|
13.1 percentage of participants
|
19.5 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Month 42 to Month 45 (n=889, 921, 261)
|
25.5 percentage of participants
|
23.9 percentage of participants
|
39.1 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Overall (n= 1389, 1392, 518)
|
49.7 percentage of participants
|
50.7 percentage of participants
|
87.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Year 4Population: Safety set where data were available.
Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug. Note: A transcription error occurred in the reporting of 1 proinsulin value for a patient in the alogliptin 25 mg completed group, for whom a partial patient ID number was mistakenly entered as an end-of-treatment proinsulin level.
Outcome measures
| Measure |
Alogliptin 12.5 mg
n=1277 Participants
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=1263 Participants
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=393 Participants
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Change From Baseline in Proinsulin Level
Baseline
|
26.1 pmol/L
Standard Deviation 25.99
|
25.4 pmol/L
Standard Deviation 30.28
|
40.2 pmol/L
Standard Deviation 36.47
|
|
Change From Baseline in Proinsulin Level
Change from Baseline
|
4.1 pmol/L
Standard Deviation 27.09
|
39.7 pmol/L
Standard Deviation 1243.37
|
-3.3 pmol/L
Standard Deviation 31.45
|
SECONDARY outcome
Timeframe: Baseline and Year 4Population: Safety set where data was available. Does not include patients enrolled in Protocol 01-05-TL-OPI322-001 or Protocol 01-06-TL-OPI322-002.
The change from Baseline in fasting insulin at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.
Outcome measures
| Measure |
Alogliptin 12.5 mg
n=537 Participants
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=526 Participants
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=212 Participants
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Change From Baseline in Insulin Level
Change from Baseline
|
2.45 μIU/mL
Standard Deviation 42.706
|
2.13 μIU/mL
Standard Deviation 16.496
|
5.62 μIU/mL
Standard Deviation 23.197
|
|
Change From Baseline in Insulin Level
Baseline
|
15.19 μIU/mL
Standard Deviation 9.898
|
15.50 μIU/mL
Standard Deviation 12.608
|
18.64 μIU/mL
Standard Deviation 15.845
|
SECONDARY outcome
Timeframe: Baseline and Year 4Population: Safety set where data was available. Patients enrolled in Protocol 01-05-TL-OPI322-001 or Protocol 01-06-TL-OPI322-002 are not included.
C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.
Outcome measures
| Measure |
Alogliptin 12.5 mg
n=615 Participants
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=615 Participants
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=322 Participants
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Change From Baseline in C-peptide Level
Baseline
|
3.406 ng/mL
Standard Deviation 1.5115
|
3.323 ng/mL
Standard Deviation 1.5945
|
3.572 ng/mL
Standard Deviation 1.7531
|
|
Change From Baseline in C-peptide Level
Change from Baseline
|
-0.471 ng/mL
Standard Deviation 1.6464
|
-0.439 ng/mL
Standard Deviation 1.2783
|
-0.641 ng/mL
Standard Deviation 1.5804
|
SECONDARY outcome
Timeframe: Baseline and Year 4Population: Safety set for whom data was available.
Change from Baseline in body weight to the last post-baseline observation collected within 7 days after the last dose of open-label study drug.
Outcome measures
| Measure |
Alogliptin 12.5 mg
n=1387 Participants
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=1385 Participants
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=518 Participants
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Change From Baseline in Body Weight
Baseline
|
86.12 kg
Standard Deviation 19.376
|
86.61 kg
Standard Deviation 19.185
|
88.62 kg
Standard Deviation 20.947
|
|
Change From Baseline in Body Weight
Change from Baseline
|
-0.64 kg
Standard Deviation 5.283
|
-0.61 kg
Standard Deviation 5.428
|
0.25 kg
Standard Deviation 5.036
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, every 3 months up to 4 years, and 1 Day after final dose.Population: Safety set.
Clinical response was defined based on the absolute value of HbA1c meeting one of two clinical targets at any post-baseline visit: * HbA1c ≤6.5%; * HbA1c ≤7.0%.
Outcome measures
| Measure |
Alogliptin 12.5 mg
n=1395 Participants
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=1398 Participants
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=527 Participants
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Percentage of Participants With a Clinical Response
HbA1c ≤6.5%
|
34.8 percentage of participants
|
34.1 percentage of participants
|
11.0 percentage of participants
|
|
Percentage of Participants With a Clinical Response
HbA1c ≤7.0%
|
64.1 percentage of participants
|
65.5 percentage of participants
|
27.1 percentage of participants
|
Adverse Events
Alogliptin 12.5 mg
Serious events: 233 serious events
Other events: 876 other events
Deaths: 0 deaths
Alogliptin 25 mg
Serious events: 228 serious events
Other events: 898 other events
Deaths: 0 deaths
Rescued: Alogliptin 25 mg
Serious events: 83 serious events
Other events: 333 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin 12.5 mg
n=1394 participants at risk
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=1399 participants at risk
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=527 participants at risk
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.50%
7/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.79%
11/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.76%
4/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.36%
5/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.50%
7/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.95%
5/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.36%
5/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.43%
6/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.76%
4/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Angina pectoris
|
0.36%
5/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.36%
5/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.38%
2/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Angina unstable
|
0.43%
6/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.38%
2/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.50%
7/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.29%
4/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.38%
2/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.38%
2/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Palpitations
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Congenital, familial and genetic disorders
MELAS syndrome
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Endocrine disorders
Goitre
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Eye disorders
Cataract
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Eye disorders
Diabetic retinopathy
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Eye disorders
Glaucoma
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Eye disorders
Iridocyclitis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.29%
4/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.22%
3/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.22%
3/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Haematemesis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Peritonitis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
General disorders
Non-cardiac chest pain
|
0.29%
4/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.29%
4/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.38%
2/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
General disorders
Chest pain
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.38%
2/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
General disorders
Death
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.22%
3/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.29%
4/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.38%
2/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.29%
4/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Hepatobiliary disorders
Biliary colic
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Hepatobiliary disorders
Hepatitis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Hepatobiliary disorders
Perforation bile duct
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Immune system disorders
Allergic oedema
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Pneumonia
|
0.93%
13/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.43%
6/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Cellulitis
|
0.29%
4/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.76%
4/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.36%
5/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.29%
4/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Erysipelas
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Osteomyelitis
|
0.22%
3/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Diverticulitis
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Gangrene
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Postoperative wound infection
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Abscess limb
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Appendicitis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Dengue fever
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Diabetic foot infection
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Infected skin ulcer
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.38%
2/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Viral infection
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Acquired immunodeficiency syndrome
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Arthritis bacterial
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Cholecystitis infective
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Coccidioidomycosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Herpes zoster
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Lymphangitis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Pyelonephritis acute
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.22%
3/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Device occlusion
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.57%
3/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemic seizure
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.22%
3/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.43%
6/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.43%
6/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.22%
3/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Tendon calcification
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.38%
2/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm benign
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the appendix
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system neoplasm
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix neoplasm
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Focal nodular hyperplasia
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Langerhans' cell granulomatosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oligodendroglioma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenom
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.43%
6/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.76%
4/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.43%
6/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Syncope
|
0.29%
4/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Convulsion
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.22%
3/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Dizziness
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Brain stem syndrome
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Diabetic mononeuropathy
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Dysarthria
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Embolic stroke
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Grand mal convulsion
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Presyncope
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Radial nerve palsy
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Vascular headache
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Psychiatric disorders
Hypnagogic hallucination
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Psychiatric disorders
Panic attack
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.50%
7/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.36%
5/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.22%
3/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Renal colic
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Postrenal failure
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.21%
3/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Colpocele
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.14%
2/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Reproductive system and breast disorders
Vocal cord polyp
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Vascular disorders
Hypertension
|
0.14%
2/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.07%
1/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Vascular disorders
Hypertensive crisis
|
0.07%
1/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.00%
0/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
0.19%
1/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
Other adverse events
| Measure |
Alogliptin 12.5 mg
n=1394 participants at risk
Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
|
Alogliptin 25 mg
n=1399 participants at risk
Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
|
Rescued: Alogliptin 25 mg
n=527 participants at risk
Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
14.8%
207/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
14.5%
203/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
16.1%
85/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
155/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
11.7%
163/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
13.5%
71/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.6%
162/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
10.9%
153/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
9.3%
49/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
133/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
11.6%
162/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
8.3%
44/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Influenza
|
8.1%
113/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
9.4%
132/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
8.0%
42/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
108/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
8.2%
115/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
10.1%
53/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
118/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
7.7%
108/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
7.0%
37/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
102/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
7.9%
111/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
8.7%
46/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Nervous system disorders
Headache
|
6.5%
90/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
7.5%
105/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
7.6%
40/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Bronchitis
|
6.7%
94/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
7.9%
111/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
4.9%
26/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
5.7%
80/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
5.7%
80/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
5.7%
30/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
General disorders
Oedema peripheral
|
5.0%
70/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
6.0%
84/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
5.7%
30/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
84/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
5.1%
72/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
5.1%
27/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
67/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
5.7%
80/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
6.1%
32/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Pharyngitis
|
4.8%
67/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
4.9%
69/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
5.1%
27/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Infections and infestations
Sinusitis
|
5.0%
70/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
4.6%
64/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
4.4%
23/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.9%
54/1394 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
4.4%
62/1399 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
5.3%
28/527 • Treatment-emergent adverse events (AEs) were defined as any AEs that started on or after the date of the first dose of open-label study drug and within 14 days after the date of the last dose of open-label study drug.
At each study visit, the investigator assessed whether any events had occurred. Participants could report events at any other time during the study.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER