Trial Outcomes & Findings for A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL) (NCT NCT01144364)
NCT ID: NCT01144364
Last Updated: 2017-08-15
Results Overview
PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
234 participants
Primary outcome timeframe
12, 24, and 34 months
Results posted on
2017-08-15
Participant Flow
Participant milestones
| Measure |
Induction Phase-Immunochemotherapy Rituximab-FND (R-FND)
Cycles 1 to 4: Participants received rituximab: 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1\*, fludarabine (F): 25 mg/m\^2 IV on Days 2-4\*, mitoxantrone (N): 10 mg/m\^2 IV on Day 2\*, dexamethasone (D) 10 mg IV (total dose) on Days 2-4\*. Cycles were repeated every 28 days for a total of 4 cycles. \*In Cycle 1, rituximab was given on Day 8 in order to avoid tumour lysis syndrome. Consequently, in Cycle 1, fludarabine and dexamethasone were given on Days 1, 2, and 3. Mitoxantrone was given on Day 1.
|
Rituximab Induction, Rituximab Maintenance
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|---|
|
Induction Phase
STARTED
|
234
|
0
|
0
|
|
Induction Phase
COMPLETED
|
202
|
0
|
0
|
|
Induction Phase
NOT COMPLETED
|
32
|
0
|
0
|
|
Follow-Up/Maintenance Phase
STARTED
|
0
|
101
|
101
|
|
Follow-Up/Maintenance Phase
COMPLETED
|
0
|
66
|
60
|
|
Follow-Up/Maintenance Phase
NOT COMPLETED
|
0
|
35
|
41
|
Reasons for withdrawal
| Measure |
Induction Phase-Immunochemotherapy Rituximab-FND (R-FND)
Cycles 1 to 4: Participants received rituximab: 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1\*, fludarabine (F): 25 mg/m\^2 IV on Days 2-4\*, mitoxantrone (N): 10 mg/m\^2 IV on Day 2\*, dexamethasone (D) 10 mg IV (total dose) on Days 2-4\*. Cycles were repeated every 28 days for a total of 4 cycles. \*In Cycle 1, rituximab was given on Day 8 in order to avoid tumour lysis syndrome. Consequently, in Cycle 1, fludarabine and dexamethasone were given on Days 1, 2, and 3. Mitoxantrone was given on Day 1.
|
Rituximab Induction, Rituximab Maintenance
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|---|
|
Induction Phase
Disease progression
|
14
|
0
|
0
|
|
Induction Phase
Adverse Event
|
9
|
0
|
0
|
|
Induction Phase
Death
|
1
|
0
|
0
|
|
Induction Phase
Withdrawal by Subject
|
1
|
0
|
0
|
|
Induction Phase
Lost to Follow-up
|
2
|
0
|
0
|
|
Induction Phase
Physician Decision
|
1
|
0
|
0
|
|
Induction Phase
Stable disease
|
2
|
0
|
0
|
|
Induction Phase
Secondary neoplasia
|
1
|
0
|
0
|
|
Induction Phase
Protocol Violation
|
1
|
0
|
0
|
|
Follow-Up/Maintenance Phase
Disease progression
|
0
|
23
|
29
|
|
Follow-Up/Maintenance Phase
Adverse Event
|
0
|
3
|
1
|
|
Follow-Up/Maintenance Phase
Death
|
0
|
2
|
0
|
|
Follow-Up/Maintenance Phase
Withdrawal by Subject
|
0
|
1
|
1
|
|
Follow-Up/Maintenance Phase
Lost to Follow-up
|
0
|
1
|
4
|
|
Follow-Up/Maintenance Phase
Relapse
|
0
|
5
|
5
|
|
Follow-Up/Maintenance Phase
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
Baseline characteristics by cohort
| Measure |
Rituximab Induction, Rituximab Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
65 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12, 24, and 34 monthsPopulation: ITT population
PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.
Outcome measures
| Measure |
Rituximab Induction, Rituximab Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|
|
Percentage of Participants With Disease Progression or Death
|
29.7 percentage of participants
|
34.7 percentage of participants
|
PRIMARY outcome
Timeframe: 12, 24, and 34 monthsPopulation: ITT population
PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Rituximab Induction, Rituximab Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|
|
PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months
12 months
|
92.0 percentage of participants
Interval 84.7 to 95.9
|
82.5 percentage of participants
Interval 73.4 to 88.8
|
|
PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months
24 months
|
81.0 percentage of participants
Interval 71.8 to 87.4
|
68.9 percentage of participants
Interval 58.7 to 77.2
|
|
PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months
34 months
|
70.4 percentage of participants
Interval 60.2 to 78.4
|
62.3 percentage of participants
Interval 51.2 to 71.5
|
SECONDARY outcome
Timeframe: 12, 24, and 36 monthsPopulation: IP population
PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method.
Outcome measures
| Measure |
Rituximab Induction, Rituximab Maintenance
n=234 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|
|
Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months
12 months
|
90.1 percentage of participants
Interval 85.5 to 93.3
|
—
|
|
Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months
24 months
|
77.8 percentage of participants
Interval 71.8 to 82.6
|
—
|
|
Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months
36 months
|
65.7 percentage of participants
Interval 59.2 to 71.5
|
—
|
SECONDARY outcome
Timeframe: 12, 24, and 36 monthsPopulation: ITT population
DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method.
Outcome measures
| Measure |
Rituximab Induction, Rituximab Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|
|
Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months
12 months
|
93.0 percentage of participants
Interval 85.8 to 96.6
|
82.5 percentage of participants
Interval 73.4 to 88.8
|
|
Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months
24 months
|
82.7 percentage of participants
Interval 73.7 to 88.9
|
68.9 percentage of participants
Interval 58.7 to 77.2
|
|
Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months
36 months
|
69.2 percentage of participants
Interval 57.9 to 78.1
|
62.3 percentage of participants
Interval 51.2 to 71.5
|
SECONDARY outcome
Timeframe: 12, 24, and 34 monthsPopulation: ITT population.
OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.
Outcome measures
| Measure |
Rituximab Induction, Rituximab Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|
|
Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months
34 months
|
96.0 percentage of participants
Interval 89.7 to 98.5
|
95.8 percentage of participants
Interval 89.2 to 98.4
|
|
Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months
12 months
|
97.0 percentage of participants
Interval 91.0 to 99.0
|
100 percentage of participants
No participants had an event, therefore 95 percent (%) confidence interval (CI) could not be determined.
|
|
Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months
24 months
|
96.0 percentage of participants
Interval 89.7 to 98.5
|
96.9 percentage of participants
Interval 90.6 to 99.0
|
SECONDARY outcome
Timeframe: 12, 24, and 34 monthsPopulation: ITT population.
OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.
Outcome measures
| Measure |
Rituximab Induction, Rituximab Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|
|
Overall Survival (OS) From Randomization - Percentage of Participants With Death
|
5.0 percentage of participants
|
4.0 percentage of participants
|
SECONDARY outcome
Timeframe: 12, 24, and 36 monthsPopulation: IP population
OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.
Outcome measures
| Measure |
Rituximab Induction, Rituximab Maintenance
n=234 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|
|
OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months
12 months
|
94.9 percentage of participants
Interval 91.1 to 97.0
|
—
|
|
OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months
24 months
|
92.7 percentage of participants
Interval 88.4 to 95.4
|
—
|
|
OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months
36 months
|
89.5 percentage of participants
Interval 84.8 to 92.9
|
—
|
SECONDARY outcome
Timeframe: Months 1 to 8Population: ITT population.
Participants without a response assessment (due to any reasons) were considered as non-responders.
Outcome measures
| Measure |
Rituximab Induction, Rituximab Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
n=101 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|
|
Percentage of Participants With a Response During the Induction Phase
Complete remission (CR/CRu)
|
79.2 percentage of participants
|
79.2 percentage of participants
|
|
Percentage of Participants With a Response During the Induction Phase
Partial remission
|
19.8 percentage of participants
|
19.8 percentage of participants
|
|
Percentage of Participants With a Response During the Induction Phase
Stable disease
|
1.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Response During the Induction Phase
Progression disease
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With a Response During the Induction Phase
Missing
|
0.0 percentage of participants
|
1.0 percentage of participants
|
SECONDARY outcome
Timeframe: Months 5 and 8Population: IP population; only participants with a positive bcl-2/IgH (NHL marker) at baseline were included in the analysis.
Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma \[NHL\] marker) at baseline, whose laboratory values were undetectable after treatment.
Outcome measures
| Measure |
Rituximab Induction, Rituximab Maintenance
n=118 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|
|
Percentage of Participants With a Molecular Response in the Induction Phase
Month 5
|
36.4 percentage of participants
|
—
|
|
Percentage of Participants With a Molecular Response in the Induction Phase
Month 8
|
58.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Months 12, 24, and 34Population: ITT Population
Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method.
Outcome measures
| Measure |
Rituximab Induction, Rituximab Maintenance
n=100 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
n=99 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|
|
Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months
24 Months
|
83.6 percentage of participants
Interval 74.6 to 89.6
|
68.6 percentage of participants
Interval 58.3 to 76.9
|
|
Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months
34 Months
|
69.9 percentage of participants
Interval 58.5 to 78.7
|
61.9 percentage of participants
Interval 50.9 to 71.2
|
|
Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months
12 Months
|
93.9 percentage of participants
Interval 86.9 to 97.2
|
82.3 percentage of participants
Interval 73.1 to 88.6
|
SECONDARY outcome
Timeframe: Months 12, 24, and 34Population: ITT Population
DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL.
Outcome measures
| Measure |
Rituximab Induction, Rituximab Maintenance
n=100 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance
n=99 Participants
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|
|
Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months
12 Months
|
6.1 percentage of participants
Interval 1.3 to 10.8
|
17.7 percentage of participants
Interval 10.0 to 25.3
|
|
Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months
24 Months
|
16.2 percentage of participants
Interval 8.9 to 23.5
|
31.4 percentage of participants
Interval 22.0 to 40.8
|
|
Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months
34 Months
|
29.5 percentage of participants
Interval 19.5 to 39.6
|
38.0 percentage of participants
Interval 27.8 to 48.3
|
Adverse Events
Rituximab Induction (Induction Phase Only)
Serious events: 19 serious events
Other events: 230 other events
Deaths: 0 deaths
Rituximab Induction, Rituximab Maintenance (Follow-up Phase)
Serious events: 19 serious events
Other events: 73 other events
Deaths: 0 deaths
Rituximab Induction, Observation Maintenance (Follow-up Phase)
Serious events: 17 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab Induction (Induction Phase Only)
n=233 participants at risk
Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses).
|
Rituximab Induction, Rituximab Maintenance (Follow-up Phase)
n=101 participants at risk
Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance (Follow-up Phase)
n=101 participants at risk
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Immune system disorders
Pyrexia
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Febrile neutropenia
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Hepatitis B
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Pneumonitis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Sepsis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Spinal compression fracture
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Chest pain
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Vascular disorders
Pulmonary embolism
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Cardiac ablation
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Endocrine disorders
Diabetic vascular disorder
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Cholecystitis acute
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Septic shock
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Transient ischaemic shock
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sarcoidosis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Blood and lymphatic system disorders
Thrombosis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
General physical health deterioration
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Cholelithiasis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
3.0%
3/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Hip arthroplasty
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Upper limb fracture
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Eye disorders
Cataract operation
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Reproductive system and breast disorders
Ovarian adenoma
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's lymphoma
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmablastic lymphoma
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
Other adverse events
| Measure |
Rituximab Induction (Induction Phase Only)
n=233 participants at risk
Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses).
|
Rituximab Induction, Rituximab Maintenance (Follow-up Phase)
n=101 participants at risk
Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
|
Rituximab Induction, Observation Maintenance (Follow-up Phase)
n=101 participants at risk
Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Movement disorder
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Eye disorders
Conjunctivitis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
3.0%
3/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Renal and urinary disorders
Dysuria
|
1.7%
4/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
17/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
12.9%
13/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
9.9%
10/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Bronchospasm
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Bronchopneumonia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Ear infection
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Escherichia infection
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Fungal infection
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Genitourinary tract infection
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Herpes simplex
|
2.6%
6/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Herpes zoster
|
1.7%
4/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
3.0%
3/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Klebsiella infection
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Klebsiella sepsis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Onychomycosis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Pneumonia
|
1.3%
3/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Prostate infection
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Pseudomonas infection
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Respiratory tract infection
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Tonsillitis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Tooth abscess
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Vaginal candidiasis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Viral infection
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Viral DNA test positive
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Infection
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Pneumonitis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Bronchitis
|
1.3%
3/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
6.9%
7/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Lung infection
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Nasopharyngeal disorder
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
4.0%
4/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Influenza
|
3.0%
7/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
5.0%
5/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
8.9%
9/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Diverticulitis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Laryngitis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
1.3%
3/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Choking sensation
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Immune system disorders
Drug hypersensitivity
|
2.6%
6/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Immune system disorders
Hypersensitivity
|
4.7%
11/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Edema
|
4.7%
11/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Hyperpyrexia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Hyperthermia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Infusion related reaction
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Oedema
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Oedema peripheral
|
3.0%
7/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Pharyngeal oedema
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
7.9%
8/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Pyrexia
|
18.9%
44/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
7.9%
8/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
3.0%
3/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.4%
15/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
4/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
3.0%
3/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
3/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Skin
|
3.4%
8/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Neck mass
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Ear and labyrinth disorders
Altered hearing
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Ear and labyrinth disorders
Deafness
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
44.2%
103/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
96.6%
225/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
15.8%
16/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
51.5%
120/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
5.0%
5/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Atrial flutter
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Palpitations
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Ischaemia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Syncope
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Vascular disorders
Hypertension
|
3.0%
7/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Vascular disorders
Hypotension
|
1.3%
3/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Vascular disorders
Pulse pressure increased
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Asthenia
|
6.9%
16/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
4.0%
4/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
5.0%
5/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Asthenia/fatigue
|
24.5%
57/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Chills
|
1.7%
4/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Fatigue
|
1.3%
3/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Oedema mucosal
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Hypothermia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Mucosal inflammation
|
2.6%
6/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Feeling hot
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Endocrine disorders
Diabetes mellitus
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Endocrine disorders
Diabetic vascular disorder
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Endocrine disorders
Goitre
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.9%
16/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Psychiatric disorders
Insomnia
|
3.0%
7/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Weight increased
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Weight decreased
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Endocrine disorders
Thyroiditis chronic
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Abdominal ridigity
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Constipation
|
10.3%
24/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.9%
23/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
3/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Gastritis
|
2.1%
5/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
3.0%
3/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Gingivitis
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Nausea
|
18.5%
43/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Pulpitis dental
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Stomatitis
|
9.9%
23/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
8/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
3/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Anal discomfort
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Helicobacter pylori identification test positive
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Polyp colorectal
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
10/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.2%
12/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood amylase increased
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Alanine aminotransferase increased
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Beta 2 microglobulin increased
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood immunoglobulin A decreased
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood immunoglobulin G decreased
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood immunoglobulin M decreased
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.7%
4/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood uric acid increased
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.3%
3/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.7%
4/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood bilirubin increased
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood creatinine increased
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood glucose increased
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Gamma-glutamyltransferase
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Hyperkalaemia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Transaminases abnormal
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Transaminases increased
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood amylase
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Alanine aminotransferase
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Blood potassium increased
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Haemoglobin increaed
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Fistula
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Cardiac disorders
Ejection fracture decreased
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Endocrine disorders
Aptyalism
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Investigations
Total bile acids increased
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
5.0%
5/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.3%
3/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
10/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
4.0%
4/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.0%
7/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Chest pain
|
1.7%
4/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Ear and labyrinth disorders
Ear pain
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.9%
9/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
5/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
4.0%
4/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Pelvic pain
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.3%
3/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Pain
|
13.3%
31/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
12.9%
13/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
17/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone density increased
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
7/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
5.0%
5/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Psychiatric disorders
Anxiety
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Psychiatric disorders
Confusional state
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Psychiatric disorders
Depressed mood
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Psychiatric disorders
Depression
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Dizziness
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
3.0%
3/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Facial palsy
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
General disorders
Irritability
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Neuropathy
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Neuropathy: motor
|
2.1%
5/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Neuropathy: sensory
|
3.9%
9/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Paraesthesia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Paraesthesia oral
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Eye disorders
Cataract
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Eye disorders
Glaucoma
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Headache
|
3.0%
7/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
3.0%
3/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Migraine
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Psychiatric disorders
Amnesia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Eye disorders
Diplopia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Nervous system disorders
Vagotomy
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteitis deformans
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.1%
5/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
4/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Vascular disorders
Phlebitis
|
0.86%
2/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Vascular disorders
Blood pressure increased
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Vascular disorders
Carotid artery stenosis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
2.0%
2/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Renal and urinary disorders
Benign prostatic hyperplasia
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Cystitis
|
2.1%
5/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
4.0%
4/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Renal and urinary disorders
Incontinence
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Renal and urinary disorders
Micturition urgency
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Renal and urinary disorders
Pollakiuria
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.43%
1/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Renal and urinary disorders
Prostate examination abnormal
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Reproductive system and breast disorders
Vaginal burning sensation
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Bronchitis chronic
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/233 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.99%
1/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
0.00%
0/101 • Adverse events (AEs) were reported up to Month 15.
Analyses were performed including all patients receiving at least one dose of planned therapy, both on IP and ITT population. One participant in the Induction Phase did not receive any study drug was not included in the analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER