Trial Outcomes & Findings for Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS (NCT NCT00335452)
NCT ID: NCT00335452
Last Updated: 2010-11-18
Results Overview
The primary endpoint is the first occurrence of any of the following events: * Cardiovascular death (any death with a clear cardiovascular or unknown cause), * Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) * Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
25086 participants
Primary outcome timeframe
30 days
Results posted on
2010-11-18
Participant Flow
25086 patients were enrolled and randomized between June 2006 and August 2009 in 597 sites in 39 countries. Because the observed overall blinded event rate was substantially lower than expected, the number of patients to be enrolled was increased from 18000 to 20000, then to 25000.
Treatment assignment was performed through an automated voice randomization service (AreS). At the same time, the AReS provided allocation to a Clopidogrel treatment regimen according to a pre-defined randomization list and to a ASA dose according to a factorial design.
Participant milestones
| Measure |
Clopidogrel 300/75/75 mg + ASA Low Dose
Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg
|
Clopidogrel 300/75/75 mg + ASA High Dose
Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg
|
Clopidogrel 600/150/75 mg + ASA Low Dose
Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg
|
Clopidogrel 600/150/75 mg + ASA High Dose
Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6312
|
6254
|
6267
|
6253
|
|
Overall Study
TREATED WITH CLOPIDOGREL
|
6271
|
6218
|
6228
|
6217
|
|
Overall Study
TREATED WITH ASA
|
6302
|
6251
|
6261
|
6247
|
|
Overall Study
COMPLETED
|
6154
|
6107
|
6108
|
6122
|
|
Overall Study
NOT COMPLETED
|
158
|
147
|
159
|
131
|
Reasons for withdrawal
| Measure |
Clopidogrel 300/75/75 mg + ASA Low Dose
Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg
|
Clopidogrel 300/75/75 mg + ASA High Dose
Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg
|
Clopidogrel 600/150/75 mg + ASA Low Dose
Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg
|
Clopidogrel 600/150/75 mg + ASA High Dose
Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg
|
|---|---|---|---|---|
|
Overall Study
Death
|
156
|
144
|
158
|
129
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
1
|
2
|
Baseline Characteristics
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
Baseline characteristics by cohort
| Measure |
Clopidogrel 300/75/75 mg + ASA Low Dose
n=6312 Participants
|
Clopidogrel 300/75/75 mg + ASA High Dose
n=6254 Participants
|
Clopidogrel 600/150/75 mg + ASA Low Dose
n=6267 Participants
|
Clopidogrel 600/150/75 mg + ASA High Dose
n=6253 Participants
|
Total
n=25086 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
61.3 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
61.3 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Age, Customized
< 65 years
|
3792 participants
n=5 Participants
|
3740 participants
n=7 Participants
|
3787 participants
n=5 Participants
|
3735 participants
n=4 Participants
|
15054 participants
n=21 Participants
|
|
Age, Customized
65 - 74 years
|
1573 participants
n=5 Participants
|
1576 participants
n=7 Participants
|
1543 participants
n=5 Participants
|
1543 participants
n=4 Participants
|
6235 participants
n=21 Participants
|
|
Age, Customized
≥ 75 years
|
947 participants
n=5 Participants
|
937 participants
n=7 Participants
|
937 participants
n=5 Participants
|
975 participants
n=4 Participants
|
3796 participants
n=21 Participants
|
|
Age, Customized
Missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1702 Participants
n=5 Participants
|
1756 Participants
n=7 Participants
|
1671 Participants
n=5 Participants
|
1742 Participants
n=4 Participants
|
6871 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4610 Participants
n=5 Participants
|
4498 Participants
n=7 Participants
|
4596 Participants
n=5 Participants
|
4511 Participants
n=4 Participants
|
18215 Participants
n=21 Participants
|
|
Region of Enrollment
Argentina
|
182 participants
n=5 Participants
|
159 participants
n=7 Participants
|
162 participants
n=5 Participants
|
174 participants
n=4 Participants
|
677 participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
97 participants
n=5 Participants
|
100 participants
n=7 Participants
|
96 participants
n=5 Participants
|
95 participants
n=4 Participants
|
388 participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
41 participants
n=5 Participants
|
35 participants
n=7 Participants
|
35 participants
n=5 Participants
|
40 participants
n=4 Participants
|
151 participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
55 participants
n=5 Participants
|
61 participants
n=7 Participants
|
59 participants
n=5 Participants
|
53 participants
n=4 Participants
|
228 participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
292 participants
n=5 Participants
|
275 participants
n=7 Participants
|
270 participants
n=5 Participants
|
288 participants
n=4 Participants
|
1125 participants
n=21 Participants
|
|
Region of Enrollment
Bulgaria
|
111 participants
n=5 Participants
|
122 participants
n=7 Participants
|
125 participants
n=5 Participants
|
112 participants
n=4 Participants
|
470 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
349 participants
n=5 Participants
|
379 participants
n=7 Participants
|
373 participants
n=5 Participants
|
347 participants
n=4 Participants
|
1448 participants
n=21 Participants
|
|
Region of Enrollment
Chile
|
95 participants
n=5 Participants
|
85 participants
n=7 Participants
|
82 participants
n=5 Participants
|
90 participants
n=4 Participants
|
352 participants
n=21 Participants
|
|
Region of Enrollment
China
|
510 participants
n=5 Participants
|
492 participants
n=7 Participants
|
500 participants
n=5 Participants
|
515 participants
n=4 Participants
|
2017 participants
n=21 Participants
|
|
Region of Enrollment
Croatia
|
114 participants
n=5 Participants
|
145 participants
n=7 Participants
|
144 participants
n=5 Participants
|
114 participants
n=4 Participants
|
517 participants
n=21 Participants
|
|
Region of Enrollment
Czech Republic
|
257 participants
n=5 Participants
|
275 participants
n=7 Participants
|
277 participants
n=5 Participants
|
258 participants
n=4 Participants
|
1067 participants
n=21 Participants
|
|
Region of Enrollment
Estonia
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
Finland
|
132 participants
n=5 Participants
|
127 participants
n=7 Participants
|
127 participants
n=5 Participants
|
132 participants
n=4 Participants
|
518 participants
n=21 Participants
|
|
Region of Enrollment
France
|
177 participants
n=5 Participants
|
163 participants
n=7 Participants
|
165 participants
n=5 Participants
|
175 participants
n=4 Participants
|
680 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
471 participants
n=5 Participants
|
450 participants
n=7 Participants
|
453 participants
n=5 Participants
|
470 participants
n=4 Participants
|
1844 participants
n=21 Participants
|
|
Region of Enrollment
Greece
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
23 participants
n=5 Participants
|
21 participants
n=4 Participants
|
85 participants
n=21 Participants
|
|
Region of Enrollment
India
|
658 participants
n=5 Participants
|
650 participants
n=7 Participants
|
645 participants
n=5 Participants
|
646 participants
n=4 Participants
|
2599 participants
n=21 Participants
|
|
Region of Enrollment
Ireland
|
24 participants
n=5 Participants
|
13 participants
n=7 Participants
|
15 participants
n=5 Participants
|
23 participants
n=4 Participants
|
75 participants
n=21 Participants
|
|
Region of Enrollment
Israel
|
286 participants
n=5 Participants
|
272 participants
n=7 Participants
|
275 participants
n=5 Participants
|
282 participants
n=4 Participants
|
1115 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
232 participants
n=5 Participants
|
260 participants
n=7 Participants
|
258 participants
n=5 Participants
|
231 participants
n=4 Participants
|
981 participants
n=21 Participants
|
|
Region of Enrollment
Korea, Republic of
|
161 participants
n=5 Participants
|
149 participants
n=7 Participants
|
152 participants
n=5 Participants
|
165 participants
n=4 Participants
|
627 participants
n=21 Participants
|
|
Region of Enrollment
Latvia
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
62 participants
n=21 Participants
|
|
Region of Enrollment
Lithuania
|
26 participants
n=5 Participants
|
31 participants
n=7 Participants
|
30 participants
n=5 Participants
|
28 participants
n=4 Participants
|
115 participants
n=21 Participants
|
|
Region of Enrollment
Malaysia
|
29 participants
n=5 Participants
|
39 participants
n=7 Participants
|
39 participants
n=5 Participants
|
28 participants
n=4 Participants
|
135 participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
19 participants
n=5 Participants
|
17 participants
n=4 Participants
|
69 participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
46 participants
n=5 Participants
|
48 participants
n=7 Participants
|
48 participants
n=5 Participants
|
46 participants
n=4 Participants
|
188 participants
n=21 Participants
|
|
Region of Enrollment
New Zealand
|
36 participants
n=5 Participants
|
31 participants
n=7 Participants
|
29 participants
n=5 Participants
|
29 participants
n=4 Participants
|
125 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
365 participants
n=5 Participants
|
322 participants
n=7 Participants
|
325 participants
n=5 Participants
|
362 participants
n=4 Participants
|
1374 participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
47 participants
n=5 Participants
|
30 participants
n=7 Participants
|
33 participants
n=5 Participants
|
48 participants
n=4 Participants
|
158 participants
n=21 Participants
|
|
Region of Enrollment
Russian Federation
|
132 participants
n=5 Participants
|
137 participants
n=7 Participants
|
138 participants
n=5 Participants
|
131 participants
n=4 Participants
|
538 participants
n=21 Participants
|
|
Region of Enrollment
Singapore
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
15 participants
n=5 Participants
|
10 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Region of Enrollment
Slovakia
|
93 participants
n=5 Participants
|
84 participants
n=7 Participants
|
83 participants
n=5 Participants
|
92 participants
n=4 Participants
|
352 participants
n=21 Participants
|
|
Region of Enrollment
South Africa
|
24 participants
n=5 Participants
|
14 participants
n=7 Participants
|
14 participants
n=5 Participants
|
23 participants
n=4 Participants
|
75 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
264 participants
n=5 Participants
|
276 participants
n=7 Participants
|
283 participants
n=5 Participants
|
263 participants
n=4 Participants
|
1086 participants
n=21 Participants
|
|
Region of Enrollment
Sweden
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
10 participants
n=4 Participants
|
40 participants
n=21 Participants
|
|
Region of Enrollment
Switzerland
|
51 participants
n=5 Participants
|
64 participants
n=7 Participants
|
64 participants
n=5 Participants
|
48 participants
n=4 Participants
|
227 participants
n=21 Participants
|
|
Region of Enrollment
Turkey
|
79 participants
n=5 Participants
|
96 participants
n=7 Participants
|
94 participants
n=5 Participants
|
78 participants
n=4 Participants
|
347 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
34 participants
n=5 Participants
|
28 participants
n=4 Participants
|
119 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
775 participants
n=5 Participants
|
763 participants
n=7 Participants
|
759 participants
n=5 Participants
|
765 participants
n=4 Participants
|
3062 participants
n=21 Participants
|
|
Qualifying condition
Suspected Unstable Angina (UA)
|
1809 participants
n=5 Participants
|
1771 participants
n=7 Participants
|
1757 participants
n=5 Participants
|
1877 participants
n=4 Participants
|
7214 participants
n=21 Participants
|
|
Qualifying condition
Suspected MI without ST elevation (NSTEMI)
|
2662 participants
n=5 Participants
|
2662 participants
n=7 Participants
|
2668 participants
n=5 Participants
|
2539 participants
n=4 Participants
|
10531 participants
n=21 Participants
|
|
Qualifying condition
MI with ST elevation (STEMI)
|
1839 participants
n=5 Participants
|
1817 participants
n=7 Participants
|
1839 participants
n=5 Participants
|
1832 participants
n=4 Participants
|
7327 participants
n=21 Participants
|
|
Qualifying condition
Missing
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Intended PCI performed
Yes
|
4377 participants
n=5 Participants
|
4326 participants
n=7 Participants
|
4262 participants
n=5 Participants
|
4298 participants
n=4 Participants
|
17263 participants
n=21 Participants
|
|
Intended PCI performed
No
|
1935 participants
n=5 Participants
|
1928 participants
n=7 Participants
|
2005 participants
n=5 Participants
|
1955 participants
n=4 Participants
|
7823 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.
The primary endpoint is the first occurrence of any of the following events: * Cardiovascular death (any death with a clear cardiovascular or unknown cause), * Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) * Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC).
Outcome measures
| Measure |
Clopidogrel 300/75/75 mg + ASA
n=12566 Participants
Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA
n=12520 Participants
Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA Low Dose
|
Clopidogrel 600/150/75 mg + ASA High Dose
|
|---|---|---|---|---|
|
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison
CV death/MI/Stroke
|
557 participants
|
522 participants
|
—
|
—
|
|
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison
- CV death
|
222 participants
|
226 participants
|
—
|
—
|
|
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison
- MI (fatal or not)
|
274 participants
|
237 participants
|
—
|
—
|
|
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison
- Stroke (fatal or not)
|
61 participants
|
59 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The analysis is on the the ASA treated population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.
Outcome measures
| Measure |
Clopidogrel 300/75/75 mg + ASA
n=12563 Participants
Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA
n=12498 Participants
Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA Low Dose
|
Clopidogrel 600/150/75 mg + ASA High Dose
|
|---|---|---|---|---|
|
First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison
- Stroke (fatal or not)
|
55 participants
|
65 participants
|
—
|
—
|
|
First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison
CV death/MI/Stroke
|
546 participants
|
527 participants
|
—
|
—
|
|
First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison
- CV death
|
231 participants
|
211 participants
|
—
|
—
|
|
First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison
- MI (fatal or not)
|
260 participants
|
251 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.
Outcome measures
| Measure |
Clopidogrel 300/75/75 mg + ASA
n=6312 Participants
Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA
n=6254 Participants
Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA Low Dose
n=6267 Participants
|
Clopidogrel 600/150/75 mg + ASA High Dose
n=6253 Participants
|
|---|---|---|---|---|
|
First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level
|
267 participants
|
290 participants
|
282 participants
|
240 participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The intent-to-treat (ITT) analysis is done on the randomized patients who underwent PCI during the study.
Outcome measures
| Measure |
Clopidogrel 300/75/75 mg + ASA
n=8703 Participants
Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA
n=8560 Participants
Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA Low Dose
|
Clopidogrel 600/150/75 mg + ASA High Dose
|
|---|---|---|---|---|
|
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup
CV death/MI/Stroke
|
392 participants
|
330 participants
|
—
|
—
|
|
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup
- CV death
|
132 participants
|
130 participants
|
—
|
—
|
|
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup
- MI (fatal or not)
|
225 participants
|
172 participants
|
—
|
—
|
|
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup
- Stroke (fatal or not)
|
35 participants
|
28 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.
Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC.
Outcome measures
| Measure |
Clopidogrel 300/75/75 mg + ASA
n=12566 Participants
Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA
n=12520 Participants
Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA Low Dose
|
Clopidogrel 600/150/75 mg + ASA High Dose
|
|---|---|---|---|---|
|
Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison
Major bleeding
|
255 participants
|
313 participants
|
—
|
—
|
|
Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison
- Severe bleeding
|
195 participants
|
236 participants
|
—
|
—
|
|
Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison
- Major but not severe bleeding
|
65 participants
|
83 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: The analysis is on the treated patient population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.
Outcome measures
| Measure |
Clopidogrel 300/75/75 mg + ASA
n=12563 Participants
Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA
n=12498 Participants
Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA Low Dose
|
Clopidogrel 600/150/75 mg + ASA High Dose
|
|---|---|---|---|---|
|
Occurrence of Major Bleeding - ASA Dose Level Comparison
Major bleeding
|
285 participants
|
282 participants
|
—
|
—
|
|
Occurrence of Major Bleeding - ASA Dose Level Comparison
- Severe bleeding
|
215 participants
|
216 participants
|
—
|
—
|
|
Occurrence of Major Bleeding - ASA Dose Level Comparison
- Major but not severe bleeding
|
74 participants
|
73 participants
|
—
|
—
|
POST_HOC outcome
Timeframe: 30 daysPopulation: The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.
This includes definite stent thrombosis (confirmed by angiography or evidence of recent thrombus determined at autopsy or by examination of tissue retrieved following thrombectomy) and probable stent thrombosis (unexplained death having occurred after intracoronary stenting or, MI related to acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any obvious cause) after validation by the EAC.
Outcome measures
| Measure |
Clopidogrel 300/75/75 mg + ASA
n=12566 Participants
Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA
n=12520 Participants
Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
|
Clopidogrel 600/150/75 mg + ASA Low Dose
|
Clopidogrel 600/150/75 mg + ASA High Dose
|
|---|---|---|---|---|
|
Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison
Stent trombosis
|
200 participants
|
135 participants
|
—
|
—
|
|
Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison
- Definite
|
111 participants
|
58 participants
|
—
|
—
|
|
Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison
- Probable
|
89 participants
|
77 participants
|
—
|
—
|
Adverse Events
Clopidogrel 300/75/75 mg + ASA Low Dose
Serious events: 322 serious events
Other events: 0 other events
Deaths: 0 deaths
Clopidogrel 300/75/75 mg + ASA High Dose
Serious events: 329 serious events
Other events: 0 other events
Deaths: 0 deaths
Clopidogrel 600/150/75 mg + ASA Low Dose
Serious events: 372 serious events
Other events: 0 other events
Deaths: 0 deaths
Clopidogrel 600/150/75 mg + ASA High Dose
Serious events: 332 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clopidogrel 300/75/75 mg + ASA Low Dose
n=6312 participants at risk
Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg
|
Clopidogrel 300/75/75 mg + ASA High Dose
n=6254 participants at risk
Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg
|
Clopidogrel 600/150/75 mg + ASA Low Dose
n=6267 participants at risk
Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg
|
Clopidogrel 600/150/75 mg + ASA High Dose
n=6253 participants at risk
Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg
Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg
Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg
|
|---|---|---|---|---|
|
General disorders
Implant site haematoma
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Fatigue
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
5/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.11%
7/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.16%
10/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.62%
39/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.80%
50/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.91%
57/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.77%
48/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.11%
7/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.13%
8/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.11%
7/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.14%
9/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.19%
12/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.26%
16/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.29%
18/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.10%
6/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Fall
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Deep vein thrombosis postoperative
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Haemolytic transfusion reaction
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Agitation postoperative
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication pulmonary
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Complication of device removal
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Mechanical ventilation complication
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.21%
13/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.19%
12/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.24%
15/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.24%
15/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.14%
9/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.13%
8/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.10%
6/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.10%
6/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Dysphagia
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Melaena
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Pneumonia
|
0.33%
21/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.18%
11/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.35%
22/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.26%
16/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Septic shock
|
0.06%
4/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Urinary tract infection
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Postoperative wound infection
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Bronchitis
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Gastroenteritis
|
0.06%
4/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Diverticulitis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Cellulitis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Lung infection
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Post procedural infection
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Viral infection
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Graft infection
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Sepsis
|
0.06%
4/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Wound infection
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Bacteraemia
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Endocarditis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Application site infection
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Gallbladder empyema
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Influenza
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Osteomyelitis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Pyelonephritis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Gangrene
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Meningitis coxsackie viral
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Post procedural pneumonia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Endocarditis bacterial
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Escherichia sepsis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Incision site infection
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Liver abscess
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Myocarditis infectious
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Peridiverticulitis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Peritoneal infection
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Puncture site infection
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Staphylococcal mediastinitis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Infections and infestations
Urosepsis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Puncture site haemorrhage
|
0.27%
17/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.34%
21/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.35%
22/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.50%
31/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Pyrexia
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Vessel puncture site haematoma
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Chest pain
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Multi-organ failure
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Non-cardiac chest pain
|
0.06%
4/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Implant site haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Inflammation
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Necrosis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Oedema peripheral
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Application site erosion
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Gait disturbance
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
General disorders
Mechanical complication of implant
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.08%
5/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic haemorrhage
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Renal failure acute
|
0.17%
11/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.14%
9/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.29%
18/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.16%
10/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Renal failure
|
0.11%
7/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.11%
7/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.13%
8/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.13%
8/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Haematuria
|
0.08%
5/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Nephropathy
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.24%
15/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.19%
12/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.29%
18/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.18%
11/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Pericarditis
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Interventricular septum rupture
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Cardiac tamponade
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Haemorrhage coronary artery
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Dressler's syndrome
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Left ventricular failure
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Cardiac disorders
Palpitations
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Deep vein thrombosis
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.10%
6/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.11%
7/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Haemorrhage
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Hypotension
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Hypertension
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Hypertensive crisis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Haematoma
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Shock
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Aortic dissection
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Femoral artery occlusion
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Artery dissection
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Wound haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Femoral artery dissection
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Vascular disorders
Venous haemorrhage
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.11%
7/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.10%
6/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.08%
5/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Grand mal convulsion
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Critical illness polyneuropathy
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Syncope
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Presyncope
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Convulsion
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Drop attacks
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Encephalomalacia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Brain stem syndrome
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Headache
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Migraine without aura
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Neurological symptom
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Nervous system disorders
Spinal cord infarction
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.06%
4/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Hydraemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Skin and subcutaneous tissue disorders
Henoch-schonlein purpura
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.06%
4/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Hepatobiliary disorders
Cholangitis
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Hepatobiliary disorders
Biliary colic
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hepatic neoplasm
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.03%
2/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Investigations
Haemoglobin decreased
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.08%
5/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.03%
2/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Investigations
Platelet count decreased
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Investigations
Hepatic enzyme increased
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Immune system disorders
Hypersensitivity
|
0.05%
3/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.05%
3/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Immune system disorders
Anaphylactic reaction
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Immune system disorders
Drug hypersensitivity
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Reproductive system and breast disorders
Ovarian haemorrhage
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Psychotic disorder
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Anxiety
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Bipolar i disorder
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Psychiatric disorders
Suicide attempt
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Eye disorders
Diplopia
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Eye disorders
Retinal detachment
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Eye disorders
Glaucoma
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Ear and labyrinth disorders
Vertigo
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.02%
1/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
|
Endocrine disorders
Pituitary cyst
|
0.00%
0/6312 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.02%
1/6254 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6267 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
0.00%
0/6253 • 30 days
The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the study is made jointly in the name of all wholehearted collaborators. Other papers are authored based on the contributions of the individuals to the overall study. Sub-studies with scientific merit which have received prior approvals of the Steering Committee may be published separately in the names of contributing Investigators. A copy of all manuscripts are provided to the Sponsors for their review and the final decision to publish is made by the Steering Committee.
- Publication restrictions are in place
Restriction type: OTHER