Trial Outcomes & Findings for Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation (NCT NCT00396877)
NCT ID: NCT00396877
Last Updated: 2014-10-24
Results Overview
The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee. Only the first event was counted.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
906 participants
Primary outcome timeframe
Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)
Results posted on
2014-10-24
Participant Flow
Recruitment was initially planned with a minimum of 490 participants anticipating that it would continue until a total of 172 participants reaching primary endpoint criteria is achieved. Finally 906 participants were enrolled and randomized between November 2006 and October 2009 in 134 sites in 31 countries. Actual median follow-up was 5.8 months.
A participant was considered randomized when informed consent had been obtained and there was confirmation of successful allocation of a randomization number through the study treatment allocation system (Interactive Voice Response System).
Participant milestones
| Measure |
Placebo
Reconstituted solution using Clopidogrel matching placebo powder administered once daily with a graduated syringe in the mouth or via a feeding tube.
|
Clopidogrel 0.2 mg/kg/Day
Reconstituted solution using Clopidogrel powder administered once daily with a graduated syringe in the mouth or via a feeding tube.
Route: oral or enteric
Frequency: once daily
Dose: daily dose adjusted for weight
|
|---|---|---|
|
Overall Study
STARTED
|
439
|
467
|
|
Overall Study
Treated
|
436
|
464
|
|
Overall Study
Completed Treatment
|
356
|
352
|
|
Overall Study
COMPLETED
|
433
|
459
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Reconstituted solution using Clopidogrel matching placebo powder administered once daily with a graduated syringe in the mouth or via a feeding tube.
|
Clopidogrel 0.2 mg/kg/Day
Reconstituted solution using Clopidogrel powder administered once daily with a graduated syringe in the mouth or via a feeding tube.
Route: oral or enteric
Frequency: once daily
Dose: daily dose adjusted for weight
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Parent(s)/guardian(s)'s request
|
4
|
7
|
Baseline Characteristics
Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation
Baseline characteristics by cohort
| Measure |
Placebo
n=439 Participants
|
Clopidogrel 0.2 mg/kg/Day
n=467 Participants
|
Total
n=906 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.0 days
STANDARD_DEVIATION 22.5 • n=99 Participants
|
36.1 days
STANDARD_DEVIATION 22.3 • n=107 Participants
|
36.1 days
STANDARD_DEVIATION 22.4 • n=206 Participants
|
|
Age, Customized
≤ 30 days
|
223 participants
n=99 Participants
|
238 participants
n=107 Participants
|
461 participants
n=206 Participants
|
|
Age, Customized
30 (<) - 92 days
|
216 participants
n=99 Participants
|
229 participants
n=107 Participants
|
445 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
185 Participants
n=99 Participants
|
198 Participants
n=107 Participants
|
383 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
254 Participants
n=99 Participants
|
269 Participants
n=107 Participants
|
523 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=99 Participants
|
88 participants
n=107 Participants
|
178 participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
12 participants
n=99 Participants
|
10 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Region of Enrollment
Hong Kong
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Thailand
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
16 participants
n=99 Participants
|
14 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=99 Participants
|
19 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Region of Enrollment
India
|
20 participants
n=99 Participants
|
27 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Region of Enrollment
France
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Region of Enrollment
Malaysia
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Region of Enrollment
China
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Finland
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=99 Participants
|
16 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Region of Enrollment
Egypt
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
32 participants
n=99 Participants
|
37 participants
n=107 Participants
|
69 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
24 participants
n=99 Participants
|
28 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
31 participants
n=99 Participants
|
34 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
9 participants
n=99 Participants
|
12 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
3 participants
n=99 Participants
|
7 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Region of Enrollment
Singapore
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
54 participants
n=99 Participants
|
59 participants
n=107 Participants
|
113 participants
n=206 Participants
|
|
Region of Enrollment
Norway
|
8 participants
n=99 Participants
|
8 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Weight
|
3.5 kilograms (kg)
STANDARD_DEVIATION 0.7 • n=99 Participants
|
3.4 kilograms (kg)
STANDARD_DEVIATION 0.7 • n=107 Participants
|
3.5 kilograms (kg)
STANDARD_DEVIATION 0.7 • n=206 Participants
|
|
Height
|
51.8 Centimeters (cm)
STANDARD_DEVIATION 4.6 • n=99 Participants
|
51.4 Centimeters (cm)
STANDARD_DEVIATION 4.4 • n=107 Participants
|
51.6 Centimeters (cm)
STANDARD_DEVIATION 4.5 • n=206 Participants
|
|
Type of systemic-to-pulmonary artery shunt palliation
Modified Blalock Taussig Shunt with Norwood
|
51 participants
n=99 Participants
|
62 participants
n=107 Participants
|
113 participants
n=206 Participants
|
|
Type of systemic-to-pulmonary artery shunt palliation
Modified Blalock Taussig Shunt without Norwood
|
252 participants
n=99 Participants
|
257 participants
n=107 Participants
|
509 participants
n=206 Participants
|
|
Type of systemic-to-pulmonary artery shunt palliation
Sano procedure with Norwood
|
54 participants
n=99 Participants
|
60 participants
n=107 Participants
|
114 participants
n=206 Participants
|
|
Type of systemic-to-pulmonary artery shunt palliation
Sano procedure without Norwood
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Type of systemic-to-pulmonary artery shunt palliation
Central shunt
|
38 participants
n=99 Participants
|
40 participants
n=107 Participants
|
78 participants
n=206 Participants
|
|
Type of systemic-to-pulmonary artery shunt palliation
Stent of ductus arteriosus
|
42 participants
n=99 Participants
|
42 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
Type of systemic-to-pulmonary artery shunt palliation
Not applicable
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Shunt on cardiopulmonary bypass
Yes
|
177 participants
n=99 Participants
|
194 participants
n=107 Participants
|
371 participants
n=206 Participants
|
|
Shunt on cardiopulmonary bypass
No
|
262 participants
n=99 Participants
|
273 participants
n=107 Participants
|
535 participants
n=206 Participants
|
|
Age at shunt palliation
|
16.0 days
STANDARD_DEVIATION 18.7 • n=99 Participants
|
16.2 days
STANDARD_DEVIATION 18.6 • n=107 Participants
|
16.1 days
STANDARD_DEVIATION 18.7 • n=206 Participants
|
|
Time from shunt palliation to randomization
≤ 1 week
|
116 participants
n=99 Participants
|
113 participants
n=107 Participants
|
229 participants
n=206 Participants
|
|
Time from shunt palliation to randomization
1 (<) to 2 weeks
|
105 participants
n=99 Participants
|
126 participants
n=107 Participants
|
231 participants
n=206 Participants
|
|
Time from shunt palliation to randomization
2 (<) to 4 weeks
|
117 participants
n=99 Participants
|
119 participants
n=107 Participants
|
236 participants
n=206 Participants
|
|
Time from shunt palliation to randomization
> 4 weeks
|
101 participants
n=99 Participants
|
109 participants
n=107 Participants
|
210 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)Population: The analysis was performed on the intent-to-treat (ITT) population (i.e. all randomized participants irrespective of whether or not the participant actually received study drug or the participant's compliance with the study protocol). Participants were included in the treatment group to which they were originally allocated.
The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee. Only the first event was counted.
Outcome measures
| Measure |
Placebo
n=439 Participants
|
Clopidogrel 0.2 mg/kg/Day
n=467 Participants
|
|---|---|---|
|
Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
- Cardiac procedure <120 days of thrombotic nature
|
9 participants
|
12 participants
|
|
Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
Death / Shunt Thrombosis / Cardiac Procedure
|
90 participants
|
89 participants
|
|
Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
- Death
|
60 participants
|
51 participants
|
|
Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
- Shunt thrombosis
|
21 participants
|
26 participants
|
SECONDARY outcome
Timeframe: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes firstPopulation: The analysis was performed on the exposed population (i.e. all randomized participants who received at least one dose of study drug regardless of the amount of treatment received). Participants were included in the treatment group according to the treatment received.
Bleeding events spanning from signature of the Informed Consent Form up to the last visit were collected as for any Adverse Event. The 'on-treatment' period was defined as the period from randomization up until 28 days after treatment discontinuation or final follow-up visit, whichever came first, and participants who experienced bleeding events during that period were counted.
Outcome measures
| Measure |
Placebo
n=436 Participants
|
Clopidogrel 0.2 mg/kg/Day
n=464 Participants
|
|---|---|---|
|
Number of Participants With Bleeding Events
- Leading to permanent treatment discontinuation
|
9 participants
|
9 participants
|
|
Number of Participants With Bleeding Events
Any bleeding event
|
88 participants
|
87 participants
|
|
Number of Participants With Bleeding Events
- Serious
|
32 participants
|
30 participants
|
|
Number of Participants With Bleeding Events
- Serious with an outcome of death
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes firstPopulation: The analysis was performed on the same population as previously (i.e. exposed population).
For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology. Participants who had multiple bleedings could be counted several times.
Outcome measures
| Measure |
Placebo
n=436 Participants
|
Clopidogrel 0.2 mg/kg/Day
n=464 Participants
|
|---|---|---|
|
Number of Participants According to Bleeding Type/Etiology
Spontaneous
|
60 participants
|
56 participants
|
|
Number of Participants According to Bleeding Type/Etiology
Surgical
|
10 participants
|
17 participants
|
|
Number of Participants According to Bleeding Type/Etiology
Post-traumatic
|
6 participants
|
11 participants
|
|
Number of Participants According to Bleeding Type/Etiology
Puncture (vascular access site)
|
19 participants
|
9 participants
|
Adverse Events
Placebo
Serious events: 196 serious events
Other events: 96 other events
Deaths: 0 deaths
Clopidogrel 0.2mg/kg/Day
Serious events: 234 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=436 participants at risk
|
Clopidogrel 0.2mg/kg/Day
n=464 participants at risk
|
|---|---|---|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
BRONCHITIS BACTERIAL
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
BRONCHITIS VIRAL
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
ENTEROCOCCAL BACTERAEMIA
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
FUNGAL SEPSIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
GASTROENTERITIS ADENOVIRUS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
GASTROENTERITIS ROTAVIRUS
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PYELONEPHRITIS
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
ROTAVIRUS INFECTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
UROSEPSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
VIRAL RASH
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
ABDOMINAL SEPSIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
CATHETER SEPSIS
|
0.92%
4/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
ENTEROBACTER SEPSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
ENTEROCOCCAL INFECTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
HAEMOPHILUS INFECTION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
IMPETIGO
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
INCISION SITE INFECTION
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
KLEBSIELLA BACTERAEMIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
MEDIASTINAL ABSCESS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
MENINGITIS PNEUMOCOCCAL
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PARAINFLUENZAE VIRUS INFECTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PNEUMONIA ESCHERICHIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
SEPSIS SYNDROME
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
STREPTOCOCCAL SEPSIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
ADENOVIRUS INFECTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
CANDIDA SEPSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
ENTEROCOCCAL SEPSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
GASTROENTERITIS CALICIVIRAL
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
KLEBSIELLA SEPSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
LOCALISED INFECTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
MEDIASTINITIS
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
MENINGITIS ASEPTIC
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
OTITIS MEDIA ACUTE
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PNEUMOCOCCAL SEPSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PNEUMONIA INFLUENZAL
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
POST PROCEDURAL CELLULITIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION BACTERIAL
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
VIRAL DIARRHOEA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
WOUND ABSCESS
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
WOUND SEPSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Blood and lymphatic system disorders
DEFICIENCY ANAEMIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Vascular disorders
VASCULAR STENOSIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Immune system disorders
MILK ALLERGY
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Immune system disorders
HYPOGAMMAGLOBULINAEMIA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.3%
6/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD
|
1.1%
5/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
WEIGHT GAIN POOR
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
1.4%
6/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
FOOD INTOLERANCE
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
HYPOPROTEINAEMIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIC SEIZURE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Psychiatric disorders
AGITATION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
CONVULSION
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
PARTIAL SEIZURES
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
VOCAL CORD PARALYSIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
POOR SUCKING REFLEX
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
VOCAL CORD PARESIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
CLONIC CONVULSION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
DYSKINESIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
EMBOLIC STROKE
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
ENCEPHALITIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
HYPOGLYCAEMIC ENCEPHALOPATHY
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
ISCHAEMIC CEREBRAL INFARCTION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
PHRENIC NERVE PARALYSIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE NEONATAL
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
CONVULSIONS LOCAL
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
FEBRILE CONVULSION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Ear and labyrinth disorders
MIDDLE EAR INFLAMMATION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
CYANOSIS
|
2.1%
9/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
5.2%
24/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.86%
4/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.1%
5/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.3%
6/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
BRADYCARDIA
|
0.92%
4/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.86%
4/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
CARDIAC ARREST
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.86%
4/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
RIGHT VENTRICULAR DYSFUNCTION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
CARDIAC PERFORATION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
CARDIAC DISORDER
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
CARDIAC PSEUDOANEURYSM
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
DILATATION VENTRICULAR
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
PERICARDIAL HAEMORRHAGE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
PULMONARY VALVE STENOSIS
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
RIGHT VENTRICULAR FAILURE
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
SUPRAVENTRICULAR EXTRASYSTOLES
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
TACHYCARDIA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
LOW CARDIAC OUTPUT SYNDROME
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
NODAL ARRHYTHMIA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
TRICUSPID VALVE INCOMPETENCE
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Cardiac disorders
VENTRICULAR DYSFUNCTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Vascular disorders
AORTIC STENOSIS
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Vascular disorders
VENA CAVA THROMBOSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Vascular disorders
SHOCK
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Vascular disorders
EMBOLISM
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Vascular disorders
HYPOTENSION
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.5%
11/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
3.0%
14/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.1%
5/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY ARTERY STENOSIS
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.92%
4/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.1%
5/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
DIAPHRAGMATIC PARALYSIS
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
STRIDOR
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL STENOSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE AIRWAYS DISORDER
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY VEIN STENOSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNOEA
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
NECROTISING COLITIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.3%
6/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT CONGESTION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSTENOSIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
CHYLOTHORAX
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL OEDEMA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY VEIN OCCLUSION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FATIGUE
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
TRACHEOMALACIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
APNOEA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
MEDIASTINAL HAEMATOMA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
MEDIASTINAL HAEMORRHAGE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
TRACHEAL STENOSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Respiratory, thoracic and mediastinal disorders
VOCAL CORD THICKENING
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
VOMITING
|
1.1%
5/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.1%
5/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.1%
5/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
1.6%
7/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.92%
4/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.3%
6/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.86%
4/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
ENTEROCOLITIS HAEMORRHAGIC
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
POST-TUSSIVE VOMITING
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
DUODENAL STENOSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
ENTERITIS
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
PNEUMATOSIS INTESTINALIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Hepatobiliary disorders
ACUTE HEPATIC FAILURE
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Skin and subcutaneous tissue disorders
DERMATITIS DIAPER
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS EMPHYSEMA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Renal and urinary disorders
ACUTE PRERENAL FAILURE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Renal and urinary disorders
BLADDER PROLAPSE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Renal and urinary disorders
VESICOURETERIC REFLUX
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Congenital, familial and genetic disorders
COARCTATION OF THE AORTA
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Congenital, familial and genetic disorders
LARYNGOMALACIA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Congenital, familial and genetic disorders
PULMONARY ARTERY STENOSIS CONGENITAL
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Congenital, familial and genetic disorders
PYLORIC STENOSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
General disorders
PYREXIA
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.1%
5/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
General disorders
PUNCTURE SITE HAEMORRHAGE
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
General disorders
CATHETER RELATED COMPLICATION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
General disorders
IRRITABILITY
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
General disorders
CATHETER THROMBOSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
General disorders
FEELING ABNORMAL
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
General disorders
VESSEL PUNCTURE SITE HAEMATOMA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Investigations
OXYGEN SATURATION DECREASED
|
2.3%
10/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
2.4%
11/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Investigations
BLOOD URINE PRESENT
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Investigations
PULMONARY ARTERIAL PRESSURE DECREASED
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Investigations
ASPIRATION BRONCHIAL
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Investigations
OXYGEN SATURATION INCREASED
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Investigations
PLATELET COUNT DECREASED
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Investigations
PULMONARY ARTERIAL PRESSURE INCREASED
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.92%
4/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.7%
8/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
OPERATIVE HAEMORRHAGE
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE FEVER
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
SHUNT STENOSIS
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
SUTURE RELATED COMPLICATION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
FEEDING TUBE COMPLICATION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
PNEUMOTHORAX TRAUMATIC
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
POST VACCINATION SYNDROME
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
PROCEDURAL SITE REACTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
SHUNT BLOOD FLOW EXCESSIVE
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
DEVICE BREAKAGE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
DRUG TOXICITY
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
GRAFT THROMBOSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE RESPIRATORY DISTRESS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE WOUND COMPLICATION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
SEROMA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
SHUNT MALFUNCTION
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
SHUNT OCCLUSION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
SKULL FRACTURE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
SUTURE RUPTURE
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.00%
0/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Surgical and medical procedures
ANORECTAL OPERATION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Surgical and medical procedures
CARDIOVASCULAR EVENT PROPHYLAXIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Surgical and medical procedures
URETERONEOCYSTOSTOMY
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.0%
13/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
2.4%
11/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
GASTROENTERITIS
|
3.2%
14/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
5.2%
24/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PNEUMONIA
|
2.1%
9/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
4.5%
21/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
BRONCHIOLITIS
|
2.8%
12/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
3.2%
15/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.4%
6/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.3%
6/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
VIRAL INFECTION
|
1.4%
6/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.5%
7/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
BRONCHITIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.86%
4/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.5%
7/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
WOUND INFECTION
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
INFLUENZA
|
1.1%
5/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.3%
6/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.92%
4/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.1%
5/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
SEPSIS
|
0.92%
4/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.7%
8/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.92%
4/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.86%
4/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
OTITIS MEDIA
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
PULMONARY SEPSIS
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
1.1%
5/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
ENDOCARDITIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.86%
4/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.69%
3/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.86%
4/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.86%
4/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
LUNG INFECTION
|
0.46%
2/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.65%
3/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
NOSOCOMIAL INFECTION
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS
|
0.23%
1/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.43%
2/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
RHINITIS
|
0.00%
0/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
0.22%
1/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
Other adverse events
| Measure |
Placebo
n=436 participants at risk
|
Clopidogrel 0.2mg/kg/Day
n=464 participants at risk
|
|---|---|---|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
12.2%
53/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
12.9%
60/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.5%
24/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
4.5%
21/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
VOMITING
|
4.1%
18/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
6.9%
32/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.6%
20/436 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
5.2%
24/464 • All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever came first).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months after trial completion, the Investigator can publish the results. Prior to publication, the sponsor shall review the manuscript and can request changes, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not exceeding 90 days.
- Publication restrictions are in place
Restriction type: OTHER