Trial Outcomes & Findings for 221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (NCT NCT02484547)
NCT ID: NCT02484547
Last Updated: 2021-09-02
Results Overview
CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. Mixed model for repeated measures (MMRM) analysis was used to analyze change from baseline in CDR-SB. A positive change from baseline indicates clinical decline.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1643 participants
Primary outcome timeframe
Baseline, Week 78
Results posted on
2021-09-02
Participant Flow
Participants were enrolled at 181 investigative sites in the United States, Belgium, Canada, Finland, France, Germany, Italy, Japan, Netherlands, Poland, Spain, Sweden, and Switzerland from 15 September 2015 to 13 July 2018.
A total of 1643 participants with Alzhiemer's disease were enrolled and randomized in the study. Of these, 1638 participants received the study drug in placebo-controlled (PC) period. After completing PC period, 771 participants entered and dosed in long-term extension (LTE) period and no participants completed the study due to early termination of the study.
Participant milestones
| Measure |
Placebo (PC Period)
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Low Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 High Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Late Start: Low Dose (LTE Period)
Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Late Start: High Dose (LTE Period)
Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Early Start: Low Dose (LTE Period)
Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Early Start: High Dose (LTE Period)
Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
|---|---|---|---|---|---|---|---|
|
Placebo-Controlled Period
STARTED
|
548
|
543
|
547
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
COMPLETED
|
288
|
291
|
295
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
NOT COMPLETED
|
260
|
252
|
252
|
0
|
0
|
0
|
0
|
|
Long-Term Extension Period
STARTED
|
0
|
0
|
0
|
131
|
132
|
251
|
257
|
|
Long-Term Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long-Term Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
131
|
132
|
251
|
257
|
Reasons for withdrawal
| Measure |
Placebo (PC Period)
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Low Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 High Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Late Start: Low Dose (LTE Period)
Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Late Start: High Dose (LTE Period)
Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Early Start: Low Dose (LTE Period)
Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Early Start: High Dose (LTE Period)
Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
|---|---|---|---|---|---|---|---|
|
Placebo-Controlled Period
Adverse Event
|
10
|
13
|
20
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Change of Treatment
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Consent Withdrawn
|
15
|
32
|
26
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Death
|
5
|
0
|
6
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Disease Progression
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Investigator Decision
|
2
|
2
|
5
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Lost to Follow-up
|
3
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Relocation
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Study Visit Burden
|
2
|
8
|
5
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Withdrawal by Parent/Guardian
|
4
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Placebo-Controlled Period
Reason not Specified
|
216
|
194
|
183
|
0
|
0
|
0
|
0
|
|
Long-Term Extension Period
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
3
|
2
|
|
Long-Term Extension Period
Death
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Long-Term Extension Period
Disease Progression
|
0
|
0
|
0
|
0
|
2
|
4
|
0
|
|
Long-Term Extension Period
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
|
Long-Term Extension Period
Loss of Capacity
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Long-Term Extension Period
Change of Treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Long-Term Extension Period
Consent Withdrawn
|
0
|
0
|
0
|
6
|
7
|
13
|
17
|
|
Long-Term Extension Period
Investigator Decision
|
0
|
0
|
0
|
2
|
1
|
0
|
1
|
|
Long-Term Extension Period
Relocation
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Long-Term Extension Period
Study Visit Burden
|
0
|
0
|
0
|
2
|
0
|
0
|
3
|
|
Long-Term Extension Period
Withdrawal by Parent/Guardian
|
0
|
0
|
0
|
0
|
1
|
3
|
2
|
|
Long-Term Extension Period
Reason not Specified
|
0
|
0
|
0
|
119
|
117
|
223
|
231
|
Baseline Characteristics
221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Placebo (PC Period)
n=548 Participants
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Low Dose (PC Period)
n=543 Participants
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 High Dose (PC Period)
n=547 Participants
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
Total
n=1638 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 7.40 • n=99 Participants
|
70.6 years
STANDARD_DEVIATION 7.45 • n=107 Participants
|
70.6 years
STANDARD_DEVIATION 7.47 • n=206 Participants
|
70.7 years
STANDARD_DEVIATION 7.43 • n=7 Participants
|
|
Sex: Female, Male
Female
|
290 Participants
n=99 Participants
|
269 Participants
n=107 Participants
|
284 Participants
n=206 Participants
|
843 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
258 Participants
n=99 Participants
|
274 Participants
n=107 Participants
|
263 Participants
n=206 Participants
|
795 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
47 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
128 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
431 Participants
n=99 Participants
|
432 Participants
n=107 Participants
|
422 Participants
n=206 Participants
|
1285 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported Due to Confidentiality Regulations
|
67 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
207 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethinicity · Hispanic or Latino
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethinicity · Not Hispanic or Latino
|
470 Participants
n=99 Participants
|
470 Participants
n=107 Participants
|
461 Participants
n=206 Participants
|
1401 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethinicity · Not Reported Due to Confidentiality Regulations
|
56 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
169 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethinicity · Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 78Population: ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure.
CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. Mixed model for repeated measures (MMRM) analysis was used to analyze change from baseline in CDR-SB. A positive change from baseline indicates clinical decline.
Outcome measures
| Measure |
Placebo (PC Period)
n=288 Participants
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Low Dose (PC Period)
n=290 Participants
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 High Dose (PC Period)
n=299 Participants
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
|---|---|---|---|
|
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78
|
1.74 score on a scale
Standard Error 0.115
|
1.47 score on a scale
Standard Error 0.116
|
1.35 score on a scale
Standard Error 0.115
|
SECONDARY outcome
Timeframe: Baseline, Week 78Population: ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure.
The MMSE is a widely used performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30, with lower scores over time indicating increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in MMSE. A negative change from baseline indicates clinical decline.
Outcome measures
| Measure |
Placebo (PC Period)
n=288 Participants
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Low Dose (PC Period)
n=293 Participants
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 High Dose (PC Period)
n=299 Participants
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
|---|---|---|---|
|
Change From Baseline in Mini Mental State Examination (MMSE) Score at Week 78
|
-3.3 score on a scale
Standard Error 0.22
|
-3.3 score on a scale
Standard Error 0.22
|
-2.7 score on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, Week 78Population: ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure.
ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The scale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. An increase in score over time indicates increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in ADAS-Cog 13. A positive change from baseline indicates clinical decline.
Outcome measures
| Measure |
Placebo (PC Period)
n=287 Participants
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Low Dose (PC Period)
n=289 Participants
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 High Dose (PC Period)
n=293 Participants
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
|---|---|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) at Week 78
|
5.162 score on a scale
Standard Error 0.4049
|
4.461 score on a scale
Standard Error 0.4074
|
3.763 score on a scale
Standard Error 0.4036
|
SECONDARY outcome
Timeframe: Baseline, Week 78Population: ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure.
The ADCS-ADL-MCI consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the patient's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53, with lower values over time reflecting functional deterioration. MMRM analysis was used to analyze change from baseline in ADAS-ADL-MCI. A negative change from baseline indicates clinical decline.
Outcome measures
| Measure |
Placebo (PC Period)
n=283 Participants
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Low Dose (PC Period)
n=286 Participants
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 High Dose (PC Period)
n=295 Participants
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
|---|---|---|---|
|
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78
|
-4.3 score on a scale
Standard Error 0.38
|
-3.5 score on a scale
Standard Error 0.38
|
-2.5 score on a scale
Standard Error 0.38
|
Adverse Events
Placebo (PC Period)
Serious events: 81 serious events
Other events: 353 other events
Deaths: 5 deaths
BIIB037 Low Dose (PC Period)
Serious events: 72 serious events
Other events: 385 other events
Deaths: 0 deaths
BIIB037 High Dose (PC Period)
Serious events: 73 serious events
Other events: 428 other events
Deaths: 6 deaths
BIIB037 Late Start: Low Dose (LTE Period)
Serious events: 15 serious events
Other events: 55 other events
Deaths: 0 deaths
BIIB037 Late Start: High Dose (LTE Period)
Serious events: 9 serious events
Other events: 56 other events
Deaths: 0 deaths
BIIB037 Early Start: Low Dose (LTE Period)
Serious events: 25 serious events
Other events: 87 other events
Deaths: 3 deaths
BIIB037 Early Start: High Dose (LTE Period)
Serious events: 25 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (PC Period)
n=547 participants at risk
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Low Dose (PC Period)
n=544 participants at risk
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 High Dose (PC Period)
n=547 participants at risk
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Late Start: Low Dose (LTE Period)
n=131 participants at risk
Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Late Start: High Dose (LTE Period)
n=132 participants at risk
Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Early Start: Low Dose (LTE Period)
n=251 participants at risk
Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Early Start: High Dose (LTE Period)
n=257 participants at risk
Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Angina unstable
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Coronary artery disease
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.78%
2/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Myocardial infarction
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Sinus tachycardia
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Eye disorders
Retinal detachment
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Acquired oesophageal web
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Constipation
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Femoral hernia strangulated
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Ileus
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.55%
3/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Nausea
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Vomiting
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
General disorders
Asthenia
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
General disorders
Chest pain
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
General disorders
Death
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
General disorders
Discomfort
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
General disorders
Gait disturbance
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.78%
2/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
General disorders
Medical device site joint pain
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
General disorders
Non-cardiac chest pain
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
General disorders
Pyrexia
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Appendicitis
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Bronchitis
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Cystitis klebsiella
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Human anaplasmosis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Otitis media
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Pneumonia
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Sepsis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Urinary tract infection
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Urosepsis
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Accident
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Animal attack
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Cardiac contusion
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Epiphyseal fracture
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
12/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
1.7%
9/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.73%
4/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
1.5%
2/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
2.3%
6/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.55%
3/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.78%
2/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.91%
5/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.55%
3/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Investigations
Weight decreased
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.55%
3/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage iv
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medullary thyroid cancer
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma malignant
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.74%
4/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Amyloid related imaging abnormality-oedema/effusion
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.92%
5/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
1.5%
8/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Cerebral infarction
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Dizziness
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Headache
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Ischaemic stroke
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Loss of consciousness
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Seizure
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Sensorimotor disorder
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Superficial siderosis of central nervous system
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.55%
3/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Syncope
|
0.55%
3/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.73%
4/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.80%
2/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.78%
2/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Agitation
|
0.55%
3/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Behaviour disorder
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Bipolar disorder
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Delusion
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Depression
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Intentional self-injury
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Mania
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Neuropsychiatric symptoms
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Psychotic disorder
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Suicide attempt
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Renal and urinary disorders
Urethral disorder
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.76%
1/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Reproductive system and breast disorders
Spermatic cord cyst
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Respiratory, thoracic and mediastinal disorders
Lung perforation
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.39%
1/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.40%
1/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Vascular disorders
Hypertension
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Vascular disorders
Hypertensive crisis
|
0.37%
2/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Vascular disorders
Hypertensive urgency
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Vascular disorders
Hypotension
|
0.18%
1/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
Other adverse events
| Measure |
Placebo (PC Period)
n=547 participants at risk
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Low Dose (PC Period)
n=544 participants at risk
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 High Dose (PC Period)
n=547 participants at risk
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
|
BIIB037 Late Start: Low Dose (LTE Period)
n=131 participants at risk
Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Late Start: High Dose (LTE Period)
n=132 participants at risk
Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Early Start: Low Dose (LTE Period)
n=251 participants at risk
Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
BIIB037 Early Start: High Dose (LTE Period)
n=257 participants at risk
Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
29/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
7.0%
38/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
7.7%
42/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
2.3%
3/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.3%
7/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
3.6%
9/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
2.3%
6/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
27/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.3%
29/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.7%
31/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
General disorders
Fatigue
|
6.8%
37/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.0%
27/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
6.2%
34/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Nasopharyngitis
|
16.6%
91/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
13.1%
71/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
16.3%
89/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
4.6%
6/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.3%
7/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
7.2%
18/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
7.4%
19/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
41/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
7.7%
42/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
6.9%
38/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
6.1%
8/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
1.5%
2/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.2%
13/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
4.3%
11/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Infections and infestations
Urinary tract infection
|
6.6%
36/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
7.2%
39/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.3%
29/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Injury, poisoning and procedural complications
Fall
|
11.3%
62/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
10.8%
59/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
13.3%
73/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
9.9%
13/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.3%
7/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
6.0%
15/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
12.5%
32/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
31/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
3.1%
17/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
6.2%
34/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
36/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
7.0%
38/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
7.7%
42/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
6.1%
8/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
2.3%
3/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
3.6%
9/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
3.9%
10/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
|
6.8%
37/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
15.8%
86/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
19.4%
106/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
13.7%
18/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
8.3%
11/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
4.8%
12/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
8.2%
21/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Amyloid related imaging abnormality-oedema/effusion
|
2.2%
12/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
25.4%
138/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
33.5%
183/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
17.6%
23/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
23.5%
31/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
4.4%
11/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
8.6%
22/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Dizziness
|
7.9%
43/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
7.7%
42/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
10.1%
55/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Headache
|
15.4%
84/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
20.0%
109/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
19.6%
107/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
7.6%
10/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
9.8%
13/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
8.0%
20/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
7.4%
19/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Nervous system disorders
Superficial siderosis of central nervous system
|
2.6%
14/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
9.4%
51/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
13.0%
71/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
9.9%
13/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
12.9%
17/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
1.6%
4/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
3.9%
10/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Anxiety
|
3.8%
21/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.5%
30/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
3.5%
19/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Confusional state
|
2.7%
15/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
2.9%
16/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.1%
28/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Psychiatric disorders
Depression
|
5.1%
28/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.3%
29/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
4.2%
23/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
0.00%
0/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
28/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
4.4%
24/544 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
6.0%
33/547 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
3.1%
4/131 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
3.0%
4/132 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
2.8%
7/251 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
5.4%
14/257 • From First Dose to End of Study (up to 4 years)
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information.PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER